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Diabetes Care
Journal Prestige (SJR): 6.693
Citation Impact (citeScore): 8
Number of Followers: 476  
 
  Full-text available via subscription Subscription journal
ISSN (Print) 0149-5992 - ISSN (Online) 1935-5548
Published by American Diabetes Association Homepage  [4 journals]
  • Associations Between Oral Health Status and Diabetic Neuropathy in a Large
           Romanian Cohort of Patients With Diabetes
    • Authors: Jivanescu; A.; Bondor, C. I.; Pop-Busui, R.; Veresiu, I. A.; Sima, D. I.; Cosma, D.-T.; Florea, B.; Gavan, N. A.
      PubDate: 2018-09-20T12:00:28-07:00
      DOI: 10.2337/dc18-0721
      Issue No: Vol. 41, No. 10 (2018)
       
  • Electroacupuncture for Painful Diabetic Peripheral Neuropathy: A
           Multicenter, Randomized, Assessor-Blinded, Controlled Trial
    • Authors: Shin; K.-M.; Lee, S.; Lee, E. Y.; Kim, C.-H.; Kang, J. W.; Lee, C. K.; Seo, B.-N.; Kim, A.-R.; Jung, S.-Y.; Kwon, O.; Choi, S.-M.
      Keywords: Complications-Neuropathy
      PubDate: 2018-09-20T12:00:28-07:00
      DOI: 10.2337/dc18-1254
      Issue No: Vol. 41, No. 10 (2018)
       
  • In This Issue of Diabetes Care
    • Pages: 2051 - 2052
      PubDate: 2018-09-20T12:00:28-07:00
      DOI: 10.2337/dc18-ti10
      Issue No: Vol. 41, No. 10 (2018)
       
  • A Perspective on the Accuracy of Blood Glucose Meters During Pregnancy
    • Authors: Immanuel; J.; Simmons, D.
      Pages: 2053 - 2058
      Abstract: Blood glucose monitoring is fundamental for hyperglycemia management during pregnancy, but are the devices up to the job' Studies assessing the accuracy of 10 commercially available glucose meters during pregnancy showed that although>98–99% of the meter values were in the acceptable zones of the error grid for the majority of the meters, the meter performance varied, with the majority showing positive bias and a few showing minimal negative bias. The mean difference between meter and laboratory plasma values varied between –0.33 and 0.73 mmol/L. Three meters showed deviations from laboratory results with a change in maternal hematocrit levels. No meters had a total analytical error 24 h), and a lower incidence of neonatal hypoglycemia. The flash glucose monitoring system shows good accuracy in pregnant women but has not been marketed widely in the U.S. We suggest that meters cannot be assumed to be sufficiently accurate during pregnancy and that manufacturers should ensure a total error
      Keywords: Clinical Therapeutics/New Technology-Glucose Monitoring and Sensing
      PubDate: 2018-09-20T12:00:28-07:00
      DOI: 10.2337/dc18-0833
      Issue No: Vol. 41, No. 10 (2018)
       
  • John E. Gerich: Father of Modern Physiology of Glucose Homeostasis,
           Counterregulation to Hypoglycemia, and Mechanistic Treatment of Diabetes
    • Authors: Bolli G. B.
      Pages: 2059 - 2063
      Keywords: Integrated Physiology-Other Hormones
      PubDate: 2018-09-20T12:00:28-07:00
      DOI: 10.2337/dci18-0027
      Issue No: Vol. 41, No. 10 (2018)
       
  • PedsQL 3.2 Diabetes Module for Children, Adolescents, and Young Adults:
           Reliability and Validity in Type 1 Diabetes
    • Authors: Varni; J. W.; Delamater, A. M.; Hood, K. K.; Raymond, J. K.; Chang, N. T.; Driscoll, K. A.; Wong, J. C.; Yi-Frazier, J. P.; Grishman, E. K.; Faith, M. A.; Corathers, S. D.; Kichler, J. C.; Miller, J. L.; Doskey, E. M.; Heffer, R. W.; Wilson, D. P.; on behalf of the Pediatric Quality of Life Inventory 3.2 Diabetes Module Testing Study Consortium
      Pages: 2064 - 2071
      Abstract: OBJECTIVEThe objective of the study was to report on the measurement properties of the revised and updated Pediatric Quality of Life Inventory (PedsQL) 3.2 Diabetes Module for children, adolescents, and young adults with type 1 diabetes.RESEARCH DESIGN AND METHODSThe 33-item PedsQL 3.2 Diabetes Module and PedsQL Generic Core Scales were completed in a 10-site national field test study by 656 families of patients ages 2–25 years with type 1 diabetes.RESULTSThe 15-item Diabetes Symptoms Summary Score and 18-item Diabetes Management Summary Score were derived from the factor analysis of the items. The Diabetes Symptoms and Diabetes Management Summary Scores evidenced excellent reliability (patient self-report α = 0.88–0.90; parent proxy report α = 0.89–0.90). The Diabetes Symptoms and Diabetes Management Summary Scores demonstrated construct validity through medium to large effect size correlations with the Generic Core Scales Total Scale Score (r = 0.43–0.67, P < 0.001). HbA1c was significantly correlated with the Diabetes Symptoms and Diabetes Management Summary Scores (r = –0.21 to –0.29, P < 0.001). Minimal clinically important difference scores ranged from 5.05 to 5.55.CONCLUSIONSThe PedsQL 3.2 Diabetes Module Diabetes Symptoms and Diabetes Management Summary Scores demonstrated excellent measurement properties and may be useful as standardized patient-reported outcomes of diabetes symptoms and diabetes management in clinical research, clinical trials, and practice in children, adolescents, and young adults with type 1 diabetes.
      Keywords: Psychosocial, Behavioral Medicine
      PubDate: 2018-09-20T12:00:28-07:00
      DOI: 10.2337/dc17-2707
      Issue No: Vol. 41, No. 10 (2018)
       
  • Trajectory of Disability in Older Adults With Newly Diagnosed Diabetes:
           Role of Elevated Depressive Symptoms
    • Authors: Wu; C.-Y.; Terhorst, L.; Karp, J. F.; Skidmore, E. R.; Rodakowski, J.
      Pages: 2072 - 2078
      Abstract: OBJECTIVEWe examined whether the trajectory of disability differed between older adults with and without elevated depressive symptoms before and after the onset of diabetes mellitus (DM) over 10 years (2004–2014) and explored difficulties in basic and instrumental activities of daily living between the two groups.RESEARCH DESIGN AND METHODSA generalized linear mixed-model analysis was conducted using five waves (8th–12th) of Health and Retirement Study (HRS) data. We included 419 older adults who self-reported new DM diagnosis within the previous 2 years and used the Center of Epidemiologic Studies Depression Scale to measure elevated depressive symptoms. Disability was measured by 10 items defined in the HRS data set.RESULTSThe trajectory of disability differed between older adults with and without elevated depressive symptoms after newly diagnosed DM over time. Significant and clinically meaningful between-group differences were found in disability after the onset of DM (waves 10 and 11) but not before the onset of DM (waves 8 and 9). Among older adults with elevated depressive symptoms, disability at pre-DM waves (8 and 9) was significantly less than post-DM waves (10–12). Difficulties with shopping, walking, and dressing were mostly reported by older adults with elevated depressive symptoms.CONCLUSIONSOlder adults with newly diagnosed DM and elevated depressive symptoms have a clinically meaningful and faster disablement trajectory than those without elevated depressive symptoms. Future interventions may take an indicated approach to disability prevention in older adults with newly diagnosed DM, especially in those with a change in depression severity.
      Keywords: Psychosocial, Behavioral Medicine
      PubDate: 2018-09-20T12:00:28-07:00
      DOI: 10.2337/dc18-0007
      Issue No: Vol. 41, No. 10 (2018)
       
  • Lifestyle Intervention in Danish Obese Pregnant Women With Early
           Gestational Diabetes Mellitus According to WHO 2013 Criteria Does Not
           Change Pregnancy Outcomes: Results From the LiP (Lifestyle in Pregnancy)
           Study
    • Authors: Vinter; C. A.; Tanvig, M. H.; Christensen, M. H.; Ovesen, P. G.; Jorgensen, J. S.; Andersen, M. S.; McIntyre, H. D.; Jensen, D. M.
      Pages: 2079 - 2085
      Abstract: OBJECTIVETo study effects of lifestyle intervention on metabolic and clinical outcomes in obese women fulfilling the World Health Organization (WHO) 2013 diagnostic criteria for gestational diabetes mellitus (GDM) in early gestation.RESEARCH DESIGN AND METHODSSecondary analysis of data from the Lifestyle in Pregnancy (LiP) study, a lifestyle randomized controlled trial in 304 pregnant women with BMI ≥30 kg/m2. Early GDM (week 12–15) was diagnosed according to modified WHO 2013 GDM criteria: fasting venous plasma glucose ≥5.1 mmol/L and/or 2-h capillary blood glucose (CBG) ≥8.5 mmol/L (75-g oral glucose tolerance test [OGTT]). Women with treated GDM fulfilling local Danish GDM criteria (2-h CBG ≥9.0 mmol/L) (n = 16) and women with normal OGTT (n = 198) were excluded.RESULTSOf 90 women with early GDM, 36 received lifestyle intervention and 54 standard care. All were Caucasian, and median age was 29 years (interquartile range 27–33) and BMI 34.5 kg/m2 (32.3–38.1). All baseline characteristics were similar in the lifestyle intervention and standard care groups. At gestational week 28–30, the women in the lifestyle intervention group had significantly higher fasting total cholesterol and fasting LDL. All other metabolic parameters including measurements of glucose, insulin, and HOMA of insulin resistance were similar. There were more planned cesarean sections in the lifestyle intervention group (22.2 vs. 5.6%), but all other obstetric outcomes were similar.CONCLUSIONSLifestyle intervention in obese women fulfilling WHO 2013 GDM criteria in early pregnancy was not effective in improving obstetric or metabolic outcomes. Future studies should focus on interventions starting prepregnancy.
      Keywords: Pregnancy-Clinical/Epidemiology
      PubDate: 2018-09-20T12:00:28-07:00
      DOI: 10.2337/dc18-0808
      Issue No: Vol. 41, No. 10 (2018)
       
  • Long-term Relapse of Type 2 Diabetes After Roux-en-Y Gastric Bypass:
           Prediction and Clinical Relevance
    • Authors: Debedat; J.; Sokolovska, N.; Coupaye, M.; Panunzi, S.; Chakaroun, R.; Genser, L.; de Turenne, G.; Bouillot, J.-L.; Poitou, C.; Oppert, J.-M.; Blüher, M.; Stumvoll, M.; Mingrone, G.; Ledoux, S.; Zucker, J.-D.; Clement, K.; Aron-Wisnewsky, J.
      Pages: 2086 - 2095
      Abstract: OBJECTIVERoux-en-Y gastric bypass (RYGB) induces type 2 diabetes remission (DR) in 60% of patients at 1 year, yet long-term relapse occurs in half of these patients. Scoring methods to predict DR outcomes 1 year after surgery that include only baseline parameters cannot accurately predict 5-year DR (5y-DR). We aimed to develop a new score to better predict 5y-DR.RESEARCH DESIGN AND METHODSWe retrospectively included 175 RYGB patients with type 2 diabetes with 5-year follow-up. Using machine learning algorithms, we developed a scoring method, 5-year Advanced-Diabetes Remission (5y-Ad-DiaRem), predicting longer-term DR postsurgery by integrating medical history, bioclinical data, and antidiabetic treatments. The scoring method was based on odds ratios and variables significantly different between groups. This score was further validated in three independent RYGB cohorts from three European countries.RESULTSCompared with 5y-DR patients, patients who had relapsed after 5 years exhibited more severe type 2 diabetes at baseline, lost significantly less weight during the 1st year after RYGB, and regained more weight afterward. The 5y-Ad-DiaRem includes baseline (diabetes duration, number of antidiabetic treatments, and HbA1c) and 1-year follow-up parameters (glycemia, number of antidiabetic treatments, remission status, 1st-year weight loss). The 5y-Ad-DiaRem was accurate (area under the receiver operating characteristic curve [AUROC], 90%; accuracy, 85%) at predicting 5y-DR, performed better than the Diabetes Remission score (DiaRem) and the Advanced-DiaRem (AUROC, 81% and 84%; accuracy, 79% and 78%, respectively), and correctly reclassified 13 of 39 patients misclassified with the DiaRem. The 5y-Ad-DiaRem robustness was confirmed in the independent cohorts.CONCLUSIONSThe 5y-Ad-DiaRem accurately predicts 5y-DR and appears relevant to identify patients at risk for relapse. Using this score could help personalize patient care after the 1st year post-RYGB to maximize weight loss, limit weight regains, and prevent relapse.
      Keywords: Epidemiology-Clinical-Diagnosis and Screening
      PubDate: 2018-09-20T12:00:28-07:00
      DOI: 10.2337/dc18-0567
      Issue No: Vol. 41, No. 10 (2018)
       
  • Time to Treatment Intensification After Monotherapy Failure and Its
           Association With Subsequent Glycemic Control Among 93,515 Patients With
           Type 2 Diabetes
    • Authors: Desai; U.; Kirson, N. Y.; Kim, J.; Khunti, K.; King, S.; Trieschman, E.; Hellstern, M.; Hunt, P. R.; Mukherjee, J.
      Pages: 2096 - 2104
      Abstract: OBJECTIVEThe goal of this study was to evaluate the association between the timing of treatment intensification and subsequent glycemic control among patients with type 2 diabetes in whom monotherapy fails.RESEARCH DESIGN AND METHODSThis retrospective analysis of the U.K. Clinical Practice Research Datalink database focused on patients with type 2 diabetes and one or more HbA1c measurements ≥7% (≥53 mmol/mol) after ≥3 months of metformin or sulfonylurea monotherapy (first measurement meeting these criteria was taken as the study index date). Baseline (6 months before the index date) characteristics were stratified by time from the index date to intensification (early:
      Keywords: Psychosocial, Behavioral Medicine
      PubDate: 2018-09-20T12:00:28-07:00
      DOI: 10.2337/dc17-0662
      Issue No: Vol. 41, No. 10 (2018)
       
  • New-Onset Diabetes After Acute Kidney Injury Requiring Dialysis
    • Authors: Lin; Y.-F.; Lin, S.-L.; Huang, T.-M.; Yang, S.-Y.; Lai, T.-S.; Chen, L.; Wu, V.-C.; Chu, T.-S.; Wu, K.-D.; on behalf of the National Taiwan University Hospital Study Group on Acute Renal Failure (NSARF)
      Pages: 2105 - 2110
      Abstract: OBJECTIVEAcute kidney injury (AKI) is related to a high prevalence of insulin resistance. However, information is lacking on the sequelae of further metabolic change among AKI requiring dialysis in patients who could be weaned off dialysis (acute kidney disease [AKD]).RESEARCH DESIGN AND METHODSUsing the National Health Insurance Research Database from 2000 to 2010, with the exclusion of those with diabetes at the start, we identified 3,307 subjects with AKD and 9,921 matched control subjects from 963,037 hospitalized patients for the comparison of the outcomes, including new-onset diabetes and all-cause mortality.RESULTSWithin the median follow-up period of 5.99 years, AKD patients had a higher incidence of new-onset diabetes than the matched control patients (5.16% vs. 4.17% per person-year, P = 0.001). AKD patients were at higher risk of mortality than control patients (adjusted hazard ratio [aHR] 1.27 [95% CI 1.18–1.36], P < 0.001). With mortality as a competing risk, a Cox proportional hazards analysis showed that AKD patients had a higher risk of subsequent diabetes (subhazard ratio [sHR] 1.18 [95% CI 1.07–1.30], P < 0.001) compared with the matched control patients. Subgroup analysis showed that patients with baseline hypertension (aHR 1.15 [95% CI 1.04–1.28]), hyperlipidemia (aHR 1.23 [95% CI 1.02–1.48]), and gout (aHR 1.23 [95% CI 1.03–1.46]) had increased odds of developing new-onset diabetes during follow-up.CONCLUSIONSPatients who experienced AKI had a higher incidence of developing new-onset diabetes and mortality. This observation adds evidence regarding potential metabolic dysregulation after AKI.
      Keywords: Epidemiology-Clinical-Diagnosis and Screening
      PubDate: 2018-09-20T12:00:28-07:00
      DOI: 10.2337/dc17-2409
      Issue No: Vol. 41, No. 10 (2018)
       
  • A Population-Based Study of the Bidirectional Association Between
           Obstructive Sleep Apnea and Type 2 Diabetes in Three Prospective U.S.
           Cohorts
    • Authors: Huang; T.; Lin, B. M.; Stampfer, M. J.; Tworoger, S. S.; Hu, F. B.; Redline, S.
      Pages: 2111 - 2119
      Abstract: OBJECTIVEMultiple lines of evidence support a complex relationship between obstructive sleep apnea (OSA) and diabetes. However, no population-based study has evaluated the potential bidirectional association between these two highly prevalent disorders.RESEARCH DESIGN AND METHODSWe followed 146,519 participants from the Nurses' Health Study (NHS; 2002–2012), Nurses’ Health Study II (NHSII; 1995–2013), and Health Professionals Follow-up Study (HPFS; 1996–2012) who were free of diabetes, cardiovascular disease, and cancer at baseline. Cox proportional hazards models were used to estimate hazard ratios (HRs) for developing diabetes according to OSA status. In parallel, we used similar approaches to estimate risk of developing OSA according to diabetes status among 151,194 participants free of OSA, cardiovascular disease, and cancer at baseline. In all three cohorts, diagnoses of diabetes and OSA were identified by validated self-reports.RESULTSSimilar results were observed across the three cohorts. In the pooled analysis, 9,029 incident diabetes cases were identified during follow-up. After accounting for potential confounders, the HR (95% CI) for diabetes was 2.06 (1.86, 2.28) comparing those with versus without OSA. The association was attenuated but remained statistically significant after further adjusting for waist circumference and BMI (HR 1.37 [95% CI 1.24, 1.53]), with the highest diabetes risk observed for OSA concomitant with sleepiness (1.78 [1.13, 2.82]). In the second analysis, we documented 9,364 incident OSA cases during follow-up. Compared with those without diabetes, the multivariable HR (95% CI) for OSA was 1.53 (1.32, 1.77) in individuals with diabetes. Adjustment for BMI and waist circumference attenuated the association (1.08 [1.00, 1.16]); however, an increased risk was observed among those with diabetes who used insulin compared with those without diabetes (1.43 [1.11, 1.83]), particularly among women (1.60 [1.34, 1.89]).CONCLUSIONSOSA is independently associated with an increased risk of diabetes, whereas insulin-treated diabetes is independently associated with a higher risk of OSA, particularly in women. Clinical awareness of this bidirectional association may improve prevention and treatment of both diseases. Future research aimed at elucidating the mechanisms that underlie each association may identify novel intervention targets.
      Keywords: Epidemiology-Other
      PubDate: 2018-09-20T12:00:28-07:00
      DOI: 10.2337/dc18-0675
      Issue No: Vol. 41, No. 10 (2018)
       
  • Adverse Childhood Experiences and the Risk of Diabetes: Examining the
           Roles of Depressive Symptoms and Cardiometabolic Dysregulations in the
           Whitehall II Cohort Study
    • Authors: Deschenes; S. S.; Graham, E.; Kivimäki, M.; Schmitz, N.
      Pages: 2120 - 2126
      Abstract: OBJECTIVEAdverse childhood experiences (ACEs) are associated with an increased risk of diabetes in adulthood. However, the potential mediating roles of depression and cardiometabolic dysregulations in this association are not clear.RESEARCH DESIGN AND METHODSProspective data were from the Whitehall II cohort study, with the phase 5 assessment (1997–1999) serving as baseline (n = 5,093, age range = 44–68 years, 27.3% female). ACEs were retrospectively reported at phase 5. Depressive symptoms (Center for Epidemiologic Studies Depression Scale) and cardiometabolic dysregulations (inflammation, central obesity, HDL cholesterol, triglycerides, impaired fasting glucose, and hypertension) were examined at phase 7 (2002–2004). Incident diabetes was examined at phases 8–11 (2006–2013) via self-report and blood samples. Participants reporting diabetes prior to phase 8 were excluded. Statistical mediation was examined with path analysis using structural equation modeling. ACEs were modeled as an observed continuous variable, whereas depressive symptoms and cardiometabolic dysregulations were modeled as latent variables. Unstandardized probit regression coefficients with 95% CI are reported for mediation analysis.RESULTSACEs were associated with an increased likelihood of diabetes, with every addition of ACE associated with an ~11% increase in odds of diabetes (odds ratio 1.11 [95% CI 1.00, 1.24], P = 0.048). In mediation analysis, ACEs were indirectly associated with diabetes via depressive symptoms (indirect effect 0.03 [95% CI 0.02, 0.04], P < 0.001) and cardiometabolic dysregulations (indirect effect 0.03 [95% CI 0.01, 0.05], P = 0.03).CONCLUSIONSThis study provides further evidence of the detrimental psychological and physiological effects of ACEs and suggests that depression and cardiometabolic dysregulations may be pathways linking ACEs with diabetes in adulthood.
      Keywords: Psychosocial, Behavioral Medicine
      PubDate: 2018-09-20T12:00:28-07:00
      DOI: 10.2337/dc18-0932
      Issue No: Vol. 41, No. 10 (2018)
       
  • Glycemic Control and Risk of Infections Among People With Type 1 or Type 2
           Diabetes in a Large Primary Care Cohort Study
    • Authors: Critchley; J. A.; Carey, I. M.; Harris, T.; DeWilde, S.; Hosking, F. J.; Cook, D. G.
      Pages: 2127 - 2135
      Abstract: OBJECTIVEDiabetes mellitus (DM) increases the risk of infections, but the effect of better control has not been thoroughly investigated.RESEARCH DESIGN AND METHODSWith the use of English primary care data, average glycated hemoglobin (HbA1c) during 2008–2009 was estimated for 85,312 patients with DM ages 40–89 years. Infection rates during 2010–2015 compiled from primary care, linked hospital, and mortality records were estimated across 18 infection categories and further summarized as any requiring a prescription or hospitalization or as cause of death. Poisson regression was used to estimate adjusted incidence rate ratios (IRRs) by HbA1c categories across all DM, and type 1 and type 2 DM separately. IRRs also were compared with 153,341 age-sex-practice–matched controls without DM. Attributable fractions (AF%) among patients with DM were estimated for an optimal control scenario (HbA1c 6–7% [42–53 mmol/mol]).RESULTSLong-term infection risk rose with increasing HbA1c for most outcomes. Compared with patients without DM, those with DM and optimal control (HbA1c 6–7% [42–53 mmol/mol], IRR 1.41 [95% CI 1.36–1.47]) and poor control (≥11% [97 mmol/mol], 4.70 [4.24–5.21]) had elevated hospitalization risks for infection. In patients with type 1 DM and poor control, this risk was even greater (IRR 8.47 [5.86–12.24]). Comparisons within patients with DM confirmed the risk of hospitalization with poor control (2.70 [2.43–3.00]) after adjustment for duration and other confounders. AF% of poor control were high for serious infections, particularly bone and joint (46%), endocarditis (26%), tuberculosis (24%), sepsis (21%), infection-related hospitalization (17%), and mortality (16%).CONCLUSIONSPoor glycemic control is powerfully associated with serious infections and should be a high priority.
      Keywords: Epidemiology-Other
      PubDate: 2018-09-20T12:00:28-07:00
      DOI: 10.2337/dc18-0287
      Issue No: Vol. 41, No. 10 (2018)
       
  • Safety and Efficacy of Exenatide Once Weekly Plus Dapagliflozin Once Daily
           Versus Exenatide or Dapagliflozin Alone in Patients With Type 2 Diabetes
           Inadequately Controlled With Metformin Monotherapy: 52-Week Results of the
           DURATION-8 Randomized Controlled Trial
    • Authors: Jabbour; S. A.; Frias, J. P.; Hardy, E.; Ahmed, A.; Wang, H.; Öhman, P.; Guja, C.
      Pages: 2136 - 2146
      Abstract: OBJECTIVEAmong patients with type 2 diabetes uncontrolled with metformin, exenatide once weekly (QW) plus dapagliflozin combination produced greater reductions in glycemia, weight, and systolic blood pressure (SBP) at 28 weeks than exenatide QW or dapagliflozin alone (DURATION-8). Here, we investigated the safety and maintenance of efficacy at 52 weeks, after a 24-week extension.RESEARCH DESIGN AND METHODSThis phase 3, multicenter, double-blind study randomized adults with type 2 diabetes (with glycated hemoglobin [HbA1c] 8.0–12.0% [64–108 mmol/mol] and on metformin ≥1,500 mg/day) to exenatide QW (2-mg subcutaneous injection) plus once-daily dapagliflozin (10-mg oral tablet), exenatide QW plus oral placebo, or dapagliflozin plus injected placebo. Extension-period P values were nominal.RESULTSOf 1,375 patients screened, 695 were randomized (mean baseline HbA1c 9.3% [78 mmol/mol]); 81.2% completed the study, and 75.3% completed treatment. At 52 weeks, HbA1c reductions were greater with exenatide QW plus dapagliflozin (least squares mean change –1.75% [–19.1 mmol/mol]) versus exenatide QW (–1.38% [–15.1 mmol/mol]; P = 0.006) or dapagliflozin (–1.23% [–13.4 mmol/mol]; P
      Keywords: Clinical Therapeutics/New Technology-Non-Insulin Injectables
      PubDate: 2018-09-20T12:00:28-07:00
      DOI: 10.2337/dc18-0680
      Issue No: Vol. 41, No. 10 (2018)
       
  • More Similarities Than Differences Testing Insulin Glargine 300 Units/mL
           Versus Insulin Degludec 100 Units/mL in Insulin-Naive Type 2 Diabetes: The
           Randomized Head-to-Head BRIGHT Trial
    • Authors: Rosenstock; J.; Cheng, A.; Ritzel, R.; Bosnyak, Z.; Devisme, C.; Cali, A. M. G.; Sieber, J.; Stella, P.; Wang, X.; Frias, J. P.; Roussel, R.; Bolli, G. B.
      Pages: 2147 - 2154
      Abstract: OBJECTIVETo compare insulin glargine 300 units/mL (Gla-300) versus insulin degludec 100 units/mL (IDeg-100) in this first head-to-head randomized controlled trial.RESEARCH DESIGN AND METHODSBRIGHT (NCT02738151) was a multicenter, open-label, active-controlled, two-arm, parallel-group, 24-week, noninferiority study in insulin-naive patients with uncontrolled type 2 diabetes. Participants were randomized 1:1 to evening dosing with Gla-300 (N = 466) or IDeg-100 (N = 463), titrated to fasting self-monitored plasma glucose of 80–100 mg/dL. The primary end point was HbA1c change from baseline to week 24. Safety end points included incidence and event rates of hypoglycemia.RESULTSAt week 24, HbA1c improved similarly from baseline values of 8.7% (72 mmol/mol) in the Gla-300 group and 8.6% (70 mmol/mol) in the IDeg-100 group to 7.0% (53 mmol/mol)—least squares mean difference –0.05% (95% CI –0.15 to 0.05) (–0.6 mmol/mol [–1.7 to 0.6])—demonstrating noninferiority of Gla-300 versus IDeg-100 (P < 0.0001). Hypoglycemia incidence and event rates over 24 weeks were comparable with both insulins, whereas during the active titration period (0–12 weeks) the incidence and rate of anytime (24-h) confirmed hypoglycemia (≤70 and
      Keywords: Clinical Therapeutics/New Technology-Insulins
      PubDate: 2018-09-20T12:00:28-07:00
      DOI: 10.2337/dc18-0559
      Issue No: Vol. 41, No. 10 (2018)
       
  • Predictive Low-Glucose Suspend Reduces Hypoglycemia in Adults,
           Adolescents, and Children With Type 1 Diabetes in an At-Home Randomized
           Crossover Study: Results of the PROLOG Trial
    • Authors: Forlenza; G. P.; Li, Z.; Buckingham, B. A.; Pinsker, J. E.; Cengiz, E.; Wadwa, R. P.; Ekhlaspour, L.; Church, M. M.; Weinzimer, S. A.; Jost, E.; Marcal, T.; Andre, C.; Carria, L.; Swanson, V.; Lum, J. W.; Kollman, C.; Woodall, W.; Beck, R. W.
      Pages: 2155 - 2161
      Abstract: OBJECTIVEThis study evaluated a new insulin delivery system designed to reduce insulin delivery when trends in continuous glucose monitoring (CGM) glucose concentrations predict future hypoglycemia.RESEARCH DESIGN AND METHODSIndividuals with type 1 diabetes (n = 103, age 6–72 years, mean HbA1c 7.3% [56 mmol/mol]) participated in a 6-week randomized crossover trial to evaluate the efficacy and safety of a Tandem Diabetes Care t:slim X2 pump with Basal-IQ integrated with a Dexcom G5 sensor and a predictive low-glucose suspend algorithm (PLGS) compared with sensor-augmented pump (SAP) therapy. The primary outcome was CGM-measured time
      Keywords: Clinical Therapeutics/New Technology-Glucose Monitoring and Sensing
      PubDate: 2018-09-20T12:00:28-07:00
      DOI: 10.2337/dc18-0771
      Issue No: Vol. 41, No. 10 (2018)
       
  • Prognostic Values of Inflammatory and Redox Status Biomarkers on the Risk
           of Major Lower-Extremity Artery Disease in Individuals With Type 2
           Diabetes
    • Authors: Nativel; M.; Schneider, F.; Saulnier, P.-J.; Gand, E.; Ragot, S.; Meilhac, O.; Rondeau, P.; Burillo, E.; Cournot, M.; Potier, L.; Velho, G.; Marre, M.; Roussel, R.; Rigalleau, V.; Mohammedi, K.; Hadjadj, S.
      Pages: 2162 - 2169
      Abstract: OBJECTIVEInflammation and oxidative stress play an important role in the pathogenesis of lower-extremity artery disease (LEAD). We assessed the prognostic values of inflammatory and redox status biomarkers on the risk of LEAD in individuals with type 2 diabetes.RESEARCH DESIGN AND METHODSPlasma concentrations of tumor necrosis factor-α receptor 1 (TNFR1), angiopoietin-like 2, ischemia-modified albumin (IMA), fluorescent advanced glycation end products, protein carbonyls, and total reductive capacity of plasma were measured at baseline in the SURDIAGENE (Survie, Diabete de type 2 et Genetique) cohort. Major LEAD was defined as the occurrence during follow-up of peripheral revascularization or lower-limb amputation.RESULTSAmong 1,412 participants at baseline (men 58.2%, mean [SD] age 64.7 [10.6] years), 112 (7.9%) developed major LEAD during 5.6 years of follow-up. High plasma concentrations of TNFR1 (hazard ratio [95% CI] for second vs. first tertile 1.12 [0.62–2.03; P = 0.71] and third vs. first tertile 2.16 [1.19–3.92; P = 0.01]) and of IMA (2.42 [1.38–4.23; P = 0.002] and 2.04 [1.17–3.57; P = 0.01], respectively) were independently associated with an increased risk of major LEAD. Plasma concentrations of TNFR1 but not IMA yielded incremental information, over traditional risk factors, for the risk of major LEAD as follows: C-statistic change (0.036 [95% CI 0.013–0.059]; P = 0.002), integrated discrimination improvement (0.012 [0.005–0.022]; P < 0.001), continuous net reclassification improvement (NRI) (0.583 [0.294–0.847]; P < 0.001), and categorical NRI (0.171 [0.027–0.317]; P = 0.02).CONCLUSIONSIndependent associations exist between high plasma TNFR1 or IMA concentrations and increased 5.6-year risk of major LEAD in people with type 2 diabetes. TNFR1 allows incremental prognostic information, suggesting its use as a biomarker for LEAD.
      Keywords: Foot Care-Lower Extremities
      PubDate: 2018-09-20T12:00:28-07:00
      DOI: 10.2337/dc18-0695
      Issue No: Vol. 41, No. 10 (2018)
       
  • Burden of Urological Complications in Men and Women With Long-standing
           Type 1 Diabetes in the Diabetes Control and Complications
           Trial/Epidemiology of Diabetes Interventions and Complications Cohort
    • Authors: Wessells; H.; Braffett, B. H.; Holt, S. K.; Jacobson, A. M.; Kusek, J. W.; Cowie, C.; Dunn, R. L.; Sarma, A. V.; the DCCT/EDIC Study Group
      Pages: 2170 - 2177
      Abstract: OBJECTIVEType 1 diabetes has been associated with high rates of urinary and sexual problems, but the cumulative burden and overlap of these complications are unknown. We sought to determine prevalence of urological complications in persons with type 1 diabetes, associations with clinical and diabetes-related factors, and rates of emergence, persistence, and remission.RESEARCH DESIGN AND METHODSThis ancillary longitudinal study among participants in the Diabetes Control and Complications Trial (DCCT) and observational follow-up study Epidemiology of Diabetes Interventions and Complications (EDIC) (652 women and 713 men) was conducted in 2003 and 2010/2011. Urinary incontinence (UI), lower urinary tract symptoms, urinary tract infection, female sexual dysfunction, erectile dysfunction, low male sexual desire, and orgasmic dysfunction were measured with validated instruments. Logistic regression determined association of complications with demographics and clinical characteristics.RESULTSOf sexually active women completing the 2010/2011 survey, 35% reported no complications, 39% had one, 19% two, 5% three, and 2% four. In men, 31% had no complications, 36% had one, 22% two, 9% three, and 3% four. Sexual dysfunction was most prevalent (42% women and 45% men) followed by UI in women (31%) and low sexual desire in men (40%). Urological complications were associated with age, BMI, and HbA1c. Remission rates ranged from 4 to 12% over the 7-year interval between surveys.CONCLUSIONSUrological complications are prevalent and frequently co-occur in persons with type 1 diabetes. Remission rates in a minority subset indicate a rationale for future studies to mitigate the onset or impact of urological complications of diabetes.
      Keywords: Epidemiology-Diabetes Complications
      PubDate: 2018-09-20T12:00:28-07:00
      DOI: 10.2337/dc18-0255
      Issue No: Vol. 41, No. 10 (2018)
       
  • Intestinal Metaproteomics Reveals Host-Microbiota Interactions in Subjects
           at Risk for Type 1 Diabetes
    • Authors: Gavin; P. G.; Mullaney, J. A.; Loo, D.; Cao, K.-A. L.; Gottlieb, P. A.; Hill, M. M.; Zipris, D.; Hamilton-Williams, E. E.
      Pages: 2178 - 2186
      Abstract: OBJECTIVEDysbiosis of the gut microbiota has been linked to disease pathogenesis in type 1 diabetes, yet the functional consequences to the host of this dysbiosis are unknown. We investigated the functional interactions between the microbiota and the host associated with type 1 diabetes disease risk.RESEARCH DESIGN AND METHODSWe performed a cross-sectional analysis of stool samples from subjects with recent-onset type 1 diabetes (n = 33), islet autoantibody–positive subjects (n = 17), low-risk autoantibody-negative subjects (n = 29), and healthy subjects (n = 22). Metaproteomic analysis was used to identify gut- and pancreas-derived host and microbial proteins, and these data were integrated with sequencing-based microbiota profiling.RESULTSBoth human (host-derived) proteins and microbial-derived proteins could be used to differentiate new-onset and islet autoantibody–positive subjects from low-risk subjects. Significant alterations were identified in the prevalence of host proteins associated with exocrine pancreas output, inflammation, and mucosal function. Integrative analysis showed that microbial taxa associated with host proteins involved in maintaining function of the mucous barrier, microvilli adhesion, and exocrine pancreas were depleted in patients with new-onset type 1 diabetes.CONCLUSIONSThese data support that patients with type 1 diabetes have increased intestinal inflammation and decreased barrier function. They also confirmed that pancreatic exocrine dysfunction occurs in new-onset type 1 diabetes and show for the first time that this dysfunction is present in high-risk individuals before disease onset. The data identify a unique type 1 diabetes–associated signature in stool that may be useful as a means to monitor disease progression or response to therapies aimed at restoring a healthy microbiota.
      Keywords: Epidemiology-Type 1 Diabetes
      PubDate: 2018-09-20T12:00:28-07:00
      DOI: 10.2337/dc18-0777
      Issue No: Vol. 41, No. 10 (2018)
       
  • Glycemic Variation and Cardiovascular Risk in the Veterans Affairs
           Diabetes Trial
    • Authors: Zhou; J. J.; Schwenke, D. C.; Bahn, G.; Reaven, P.; for the VADT Investigators
      Pages: 2187 - 2194
      Abstract: OBJECTIVEThere is uncertainty about the importance of glycemic variability in cardiovascular complications in patients with type 2 diabetes. Using the Veterans Affairs Diabetes Trial (VADT), we investigated the association between variation in fasting glucose and glycated hemoglobin (HbA1c) over time and the incidence of cardiovascular disease (CVD) and assessed whether this is influenced by intensive or standard glycemic control.RESEARCH DESIGN AND METHODSDuring the VADT, fasting glucose and HbA1c were measured every 3 months for up to 84 months in 1,791 individuals. Variability measures included coefficient of variation (CV) and average real variability (ARV) for fasting glucose and HbA1c. Overall mean glucose and HbA1c measures as well as their maximum and the most recent measurement were also examined.RESULTSVariability measures (CV and ARV) of fasting glucose were significantly associated with CVD even after adjusting for other risk factors, including mean fasting glucose. When considering separately groups receiving intensive and standard glycemic control, this relationship was evident in the intensive treatment group but not in the standard group. Additional adjustment for severe hypoglycemic episodes did not alter the relationship between fasting glucose variability and CVD. Interestingly, no HbA1c measures were associated with CVD after adjusting for multiple baseline risk factors.CONCLUSIONSOur analysis indicates that in the VADT, variability of fasting glucose plays a role in the development of CVD complications beyond the influence of standard fasting glucose measures. The adverse consequences of fasting glucose variability on CVD appear greatest in those receiving intensive glucose control.
      Keywords: Complications-Macrovascular-Atherosclerotic Cardiovascular Disease and Human Diabetes
      PubDate: 2018-09-20T12:00:28-07:00
      DOI: 10.2337/dc18-0548
      Issue No: Vol. 41, No. 10 (2018)
       
  • LDL Cholesterol Rises With BMI Only in Lean Individuals: Cross-sectional
           U.S. and Spanish Representative Data
    • Authors: Laclaustra; M.; Lopez-Garcia, E.; Civeira, F.; Garcia-Esquinas, E.; Graciani, A.; Guallar-Castillon, P.; Banegas, J. R.; Rodriguez-Artalejo, F.
      Pages: 2195 - 2201
      Abstract: OBJECTIVEElevated LDL cholesterol (LDLc) is not strongly associated with obesity or metabolic syndrome (MS), but this relationship repeatedly has been examined assuming a linear association. This study aimed to assess the dose-response relationship between body mass index (BMI) or waist circumference (WC) and LDLc and to evaluate its link to metabolic impairment.RESEARCH DESIGN AND METHODSParticipants in the continuous National Health and Nutrition Examination Survey (NHANES, 1999–2010) (n = 12,383) and the Study on Nutrition and Cardiovascular Risk (ENRICA, 2008–2010) (n = 11,765), representative samples of U.S. and Spanish noninstitutionalized populations, were cross-sectionally investigated. LDLc was modeled with age- and sex-adjusted regressions, with BMI and/or WC as explanatory variables included in models as two-segment linear and natural cubic splines.RESULTSIn NHANES and ENRICA, slopes of the BMI-LDLc association changed (P < 0.001) at BMI 27.1 and 26.5 kg/m2, respectively, forming an inverted U shape. Below these BMI inflection points, LDLc rose 2.30 and 2.41 mg/dL per kg/m2 (both P < 0.001). However, above said points, LDLc declined –0.37 and –0.38 mg/dL per kg/m2 (both P < 0.001). The WC-LDLc relationship was similar to the BMI-LDLc relationship. Accumulation of MS traits was associated with a weakening of the positive BMI-LDLc association among lean participants (below the BMI inflection point). Aging shifted the inflection point of the BMI-LDLc relationship to lower BMI values.CONCLUSIONSThe BMI- and WC-LDLc relationships have inverted U shapes. Diminishing associations between BMI and LDLc might indicate metabolic impairment as a result of aging or other metabolic diseases. In lean individuals, small weight losses might help to lower LDLc for cardiovascular prevention.
      Keywords: Obesity-Human
      PubDate: 2018-09-20T12:00:28-07:00
      DOI: 10.2337/dc18-0372
      Issue No: Vol. 41, No. 10 (2018)
       
  • The Association Between Diabetes and Age-Related Macular Degeneration
           Among the Elderly in Taiwan
    • Authors: He; M.-S.; Chang, F.-L.; Lin, H.-Z.; Wu, J.-L.; Hsieh, T.-C.; Lee, Y.-C.
      Pages: 2202 - 2211
      Abstract: OBJECTIVETo investigate the relationship between diabetes and future development of age-related macular degeneration (AMD).RESEARCH DESIGN AND METHODSLongitudinal, retrospective cohort study data for the period between 1997 and 2012 were obtained from the Longitudinal Health Insurance Database (LHID) of Taiwan. The final available 71,904 patients with diabetes and 270,213 patients without diabetes ≥50 years of age were further matched by age, sex, and Charlson comorbidity index. In the end, 54,616 study subjects in each of the diabetes and nondiabetes groups were recruited. The stratified populations of patients with diabetes with diabetic retinopathy (DR) (n = 7,119) versus those with diabetes who do not have DR (n = 7,119) and populations of patients with proliferative DR (PDR) (n = 2,134) versus those with nonproliferative DR (NPDR) (n = 2,134) were also obtained. Competing risk regression models were used to assess the adjusted hazard ratio (HR) and 99% CI. The main outcome measures were the first-ever diagnosis of AMD during the observational period.RESULTSThe incidences of nonexudative AMD (HR 1.23; P = 0.108) and exudative AMD (HR 1.37; P = 0.023) were not significantly associated with cohorts of persons with diabetes compared with cohorts without diabetes. The stratified analysis showed that nonexudative AMD (HR 3.89; P = 0.001) and exudative AMD (HR 3.42; P < 0.001) were significantly correlated to diabetes with DR cohorts, compared with diabetes without DR cohorts. The incidences of nonexudative AMD (HR 0.53; P = 0.277) and exudative AMD (HR 2.27; P = 0.058) were not significantly different between PDR cohorts compared with NPDR cohorts.CONCLUSIONSThis study provides large-scale, population-based evidence that diabetes with retinopathy is independently associated with an increased risk of subsequent AMD development.
      PubDate: 2018-09-20T12:00:28-07:00
      DOI: 10.2337/dc18-0707
      Issue No: Vol. 41, No. 10 (2018)
       
  • Use of Vascular Assessments and Novel Biomarkers to Predict Cardiovascular
           Events in Type 2 Diabetes: The SUMMIT VIP Study
    • Authors: Shore; A. C.; Colhoun, H. M.; Natali, A.; Palombo, C.; Khan, F.; Östling, G.; Aizawa, K.; Kennbäck, C.; Casanova, F.; Persson, M.; Gooding, K.; Gates, P. E.; Looker, H.; Dove, F.; Belch, J.; Pinnola, S.; Venturi, E.; Kozakova, M.; Goncalves, I.; Kravic, J.; Björkbacka, H.; Nilsson, J.; on behalf of the SUMMIT Consortium
      Pages: 2212 - 2219
      Abstract: OBJECTIVECardiovascular disease (CVD) risk prediction represents an increasing clinical challenge in the treatment of diabetes. We used a panel of vascular imaging, functional assessments, and biomarkers reflecting different disease mechanisms to identify clinically useful markers of risk for cardiovascular (CV) events in subjects with type 2 diabetes (T2D) with or without manifest CVD.RESEARCH DESIGN AND METHODSThe study cohort consisted of 936 subjects with T2D recruited at four European centers. Carotid intima-media thickness and plaque area, ankle-brachial pressure index, arterial stiffness, endothelial function, and circulating biomarkers were analyzed at baseline, and CV events were monitored during a 3-year follow-up period.RESULTSThe CV event rate in subjects with T2D was higher in those with (n = 440) than in those without (n = 496) manifest CVD at baseline (5.53 vs. 2.15/100 life-years, P < 0.0001). New CV events in subjects with T2D with manifest CVD were associated with higher baseline levels of inflammatory biomarkers (interleukin 6, chemokine ligand 3, pentraxin 3, and hs-CRP) and endothelial mitogens (hepatocyte growth factor and vascular endothelial growth factor A), whereas CV events in subjects with T2D without manifest CVD were associated with more severe baseline atherosclerosis (median carotid plaque area 30.4 mm2 [16.1–92.2] vs. 19.5 mm2 [9.5–40.5], P = 0.01). Conventional risk factors, as well as measurements of arterial stiffness and endothelial reactivity, were not associated with CV events.CONCLUSIONSOur observations demonstrate that markers of inflammation and endothelial stress reflect CV risk in subjects with T2D with manifest CVD, whereas the risk for CV events in subjects with T2D without manifest CVD is primarily related to the severity of atherosclerosis.
      Keywords: Complications-Macrovascular-Atherosclerotic Cardiovascular Disease and Human Diabetes
      PubDate: 2018-09-20T12:00:28-07:00
      DOI: 10.2337/dc18-0185
      Issue No: Vol. 41, No. 10 (2018)
       
  • Effects of Interrupting Sedentary Behavior With Short Bouts of Moderate
           Physical Activity on Glucose Tolerance in Children With Overweight and
           Obesity: A Randomized Crossover Trial
    • Authors: Broadney; M. M.; Belcher, B. R.; Berrigan, D. A.; Brychta, R. J.; Tigner, I. L.; Shareef, F.; Papachristopoulou, A.; Hattenbach, J. D.; Davis, E. K.; Brady, S. M.; Bernstein, S. B.; Courville, A. B.; Drinkard, B. E.; Smith, K. P.; Rosing, D. R.; Wolters, P. L.; Chen, K. Y.; Yanovski, J. A.
      Pages: 2220 - 2228
      Abstract: OBJECTIVESedentary children have greater risk of developing abnormalities in glucose homeostasis. We investigated whether interrupting sedentary behavior (sitting) with very short periods of walking would improve glucose metabolism without affecting dietary intake in children with overweight or obesity. We hypothesized that interrupting sitting with short bouts of moderate-intensity walking would decrease insulin area under the curve (AUC) during an oral glucose tolerance test (OGTT) compared with uninterrupted sitting.RESEARCH DESIGN AND METHODSOverweight/obese (BMI ≥85th percentile) children 7–11 years of age underwent two experimental conditions in random order: prolonged sitting (3 h of continuous sitting) and interrupted sitting (3 min of moderate-intensity walking at 80% of ventilatory threshold every 30 min for 3 h). Insulin, C-peptide, and glucose were measured every 30 min for 3 h during an OGTT. Each session was followed by a buffet meal. Primary outcomes were differences in OGTT hormones and substrates and in buffet meal intake by condition.RESULTSAmong 35 children with complete data, mixed-model results identified lower insulin and C-peptide in the interrupted condition (P = 0.007 and P = 0.029, respectively); the intervention reduced insulin AUC by 21% (P < 0.001) and C-peptide AUC 18% (P = 0.001) and improved estimated insulin sensitivity (P = 0.013). Neither buffet total energy intake (1,262 ± 480 vs. 1,260 ± 475 kcal; P = 0.89) nor macronutrient composition of the meal (P values>0.38) differed between conditions significantly.CONCLUSIONSInterrupting sitting with brief moderate-intensity walking improved glucose metabolism without significantly increasing energy intake in children with overweight or obesity. Interrupting sedentary behavior may be a promising intervention strategy for reducing metabolic risk in such children.
      Keywords: Pediatrics-Obesity and Type 2 Diabetes
      PubDate: 2018-09-20T12:00:28-07:00
      DOI: 10.2337/dc18-0774
      Issue No: Vol. 41, No. 10 (2018)
       
  • The Impact of Liraglutide on Diabetes-Related Foot Ulceration and
           Associated Complications in Patients With Type 2 Diabetes at High Risk for
           Cardiovascular Events: Results From the LEADER Trial
    • Authors: Dhatariya; K.; Bain, S. C.; Buse, J. B.; Simpson, R.; Tarnow, L.; Kaltoft, M. S.; Stellfeld, M.; Tornoe, K.; Pratley, R. E.; the LEADER Publication Committee on behalf of the LEADER Trial Investigators
      Pages: 2229 - 2235
      Abstract: OBJECTIVEDiabetes-related foot ulcers (DFUs) and their sequelae result in large patient and societal burdens. Long-term data determining the efficacy of individual glucose-lowering agents on DFUs are lacking. Using existing data from the Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) trial, we conducted post hoc analyses assessing the impact of liraglutide versus placebo in people with type 2 diabetes and at high risk of cardiovascular (CV) events on the incidence of DFUs and their sequelae.RESEARCH DESIGN AND METHODSThe LEADER trial (NCT01179048) was a randomized, double-blind, multicenter, CV outcomes trial assessing liraglutide (1.8 mg/day) versus placebo, in addition to standard of care, for up to 5 years. Information on DFUs was collected systematically during the trial, and DFU complications were assessed post hoc through reviewing case narratives.RESULTSDuring a median of 3.8 years’ follow-up, similar proportions of patients reported at least one episode of DFU in the liraglutide and placebo groups (3.8% [176/4,668] versus 4.1% [191/4,672], respectively; hazard ratio [HR] 0.92 [95% CI 0.75, 1.13; P = 0.41]). Analysis of DFU-related complications demonstrated a significant reduction in amputations with liraglutide versus placebo (HR 0.65 [95% CI 0.45, 0.95; P = 0.03]). However, no differences were found for foot infections, involvement of underlying structures, or peripheral revascularization in the main analysis.CONCLUSIONSTreatment with liraglutide in patients with type 2 diabetes and at high risk of CV events in the LEADER trial did not increase the risk of DFU events and was associated with a significantly lower risk of DFU-related amputations compared with placebo. This association, possibly due to chance, needs further investigation.
      Keywords: Foot Care-Lower Extremities
      PubDate: 2018-09-20T12:00:28-07:00
      DOI: 10.2337/dc18-1094
      Issue No: Vol. 41, No. 10 (2018)
       
  • Success in Achieving the Targets of the 20-Year Infancy-Onset Dietary
           Intervention: Association With Insulin Sensitivity and Serum Lipids
    • Authors: Laitinen; T. T.; Nuotio, J.; Juonala, M.; Niinikoski, H.; Rovio, S.; Viikari, J. S. A.; Rönnemaa, T.; Magnussen, C. G.; Jokinen, E.; Lagström, H.; Jula, A.; Simell, O.; Raitakari, O. T.; Pahkala, K.
      Pages: 2236 - 2244
      Abstract: OBJECTIVEWe examined whether success in achieving the key targets of an infancy-onset 20-year dietary intervention associated with insulin sensitivity and serum lipids from early childhood to young adulthood.RESEARCH DESIGN AND METHODSThe sample comprised 941 children participating in the prospective, randomized Special Turku Coronary Risk Factor Intervention Project (STRIP). Dietary counseling was given biannually based on the Nordic Nutrition Recommendations with the main aim to improve the quality of dietary fat in children’s diets and the secondary aim to promote intake of vegetables, fruits, and whole-grain products. Food records and serum lipid profile were studied annually from 1 to 20 years of age, and HOMA of insulin resistance (HOMA-IR) was assessed between 7 and 20 years of age. Meeting the intervention targets for quality of dietary fat was defined as the ratio of saturated fatty acids (SAFA) to monounsaturated and polyunsaturated fatty acids (MUFA + PUFA)
      Keywords: Epidemiology-Nutrition
      PubDate: 2018-09-20T12:00:28-07:00
      DOI: 10.2337/dc18-0869
      Issue No: Vol. 41, No. 10 (2018)
       
  • Exercise Response Variations in Skeletal Muscle PCr Recovery Rate and
           Insulin Sensitivity Relate to Muscle Epigenomic Profiles in Individuals
           With Type 2 Diabetes
    • Authors: Stephens; N. A.; Brouwers, B.; Eroshkin, A. M.; Yi, F.; Cornnell, H. H.; Meyer, C.; Goodpaster, B. H.; Pratley, R. E.; Smith, S. R.; Sparks, L. M.
      Pages: 2245 - 2254
      Abstract: OBJECTIVESome individuals with type 2 diabetes do not reap metabolic benefits from exercise training, yet the underlying mechanisms of training response variation are largely unexplored. We classified individuals with type 2 diabetes (n = 17) as nonresponders (n = 6) or responders (n = 11) based on changes in phosphocreatine (PCr) recovery rate after 10 weeks of aerobic training. We aimed to determine whether the training response variation in PCr recovery rate was marked by distinct epigenomic profiles in muscle prior to training.RESEARCH DESIGN AND METHODSPCr recovery rate as an indicator of in vivo muscle mitochondrial function in vastus lateralis (31P-magnetic resonance spectroscopy), insulin sensitivity (M-value; hyperinsulinemic-euglycemic clamp), aerobic capacity (Vo2peak), and blood profiles were determined pretraining and post-training. Muscle biopsies were performed pretraining in vastus lateralis for the isolation of primary skeletal muscle cells (HSkMCs) and assessments of global DNA methylation and RNA sequencing in muscle tissue and HSkMCs.RESULTSBy design, nonresponders decreased and responders increased PCr recovery rate with training. In nonresponders, insulin sensitivity did not improve and glycemic control (HbA1c) worsened. In responders, insulin sensitivity improved. Vo2peak improved by ~12% in both groups. Nonresponders and responders were distinguished by distinct pretraining molecular (DNA methylation, RNA expression) patterns in muscle tissue, as well as in HSkMCs. Enrichment analyses identified elevations in glutathione regulation, insulin signaling, and mitochondrial metabolism in nonresponders pretraining, which was reflected in vivo by higher pretraining PCr recovery rate and insulin sensitivity in these same individuals.CONCLUSIONSA training response variation for clinical risk factors in individuals with type 2 diabetes is reflected by distinct basal myocellular epigenomic profiles in muscle tissue, some of which are maintained in HSkMCs, suggesting a cell-autonomous underpinning. Our data provide new evidence to potentially shift the diabetes treatment paradigm for individuals who do not benefit from training, such that supplemental treatment can be designed.
      Keywords: Exercise
      PubDate: 2018-09-20T12:00:28-07:00
      DOI: 10.2337/dc18-0296
      Issue No: Vol. 41, No. 10 (2018)
       
  • "Fat Shadows" From DXA for the Qualitative Assessment of Lipodystrophy:
           When a Picture Is Worth a Thousand Numbers
    • Authors: Meral; R.; Ryan, B. J.; Malandrino, N.; Jalal, A.; Neidert, A. H.; Muniyappa, R.; Akıncı, B.; Horowitz, J. F.; Brown, R. J.; Oral, E. A.
      Pages: 2255 - 2258
      Abstract: OBJECTIVELipodystrophy syndromes are a heterogeneous group of disorders associated with selective absence of fat. Currently, the diagnosis is established only clinically.RESEARCH DESIGN AND METHODSWe developed a new method from DXA scans called a "fat shadow," which is a color-coded representation highlighting only the fat tissue. We conducted a blinded retrospective validation study to assess its usefulness for the diagnosis of lipodystrophy syndromes.RESULTSWe evaluated the fat shadows from 16 patients (11 female and 5 male) with generalized lipodystrophy (GL), 57 (50 female and 7 male) with familial partial lipodystrophy (FPLD), 2 (1 female and 1 male) with acquired partial lipodystrophy, and 126 (90 female and 36 male) control subjects. FPLD was differentiated from control subjects with 85% sensitivity and 96% specificity (95% CIs 72–93 and 91–99, respectively). GL was differentiated from nonobese control subjects with 100% sensitivity and specificity (95% CIs 79–100 and 92–100, respectively).CONCLUSIONSFat shadows provided sufficient qualitative information to infer clinical phenotype and differentiate these patients from appropriate control subjects. We propose that this method could be used to support the diagnosis.
      Keywords: Obesity-Human
      PubDate: 2018-09-20T12:00:28-07:00
      DOI: 10.2337/dc18-0978
      Issue No: Vol. 41, No. 10 (2018)
       
  • Erratum. Reduction in the Incidence of Type 2 Diabetes With the
           Mediterranean Diet: Results of the PREDIMED-Reus nutrition intervention
           randomized trial. Diabetes Care 2011;34:14-19
    • Authors: Salas-Salvado; J.; Bullo, M.; Babio, N.; Martinez-Gonzalez, M. A.; Ibarrola-Jurado, N.; Basora, J.; Estruch, R.; Covas, M. I.; Corella, D.; Aros, F.; Ruiz-Gutierrez, V.; Ros, E.; for the PREDIMED Study Investigators
      Pages: 2259 - 2260
      PubDate: 2018-09-20T12:00:28-07:00
      DOI: 10.2337/dc18-er10
      Issue No: Vol. 41, No. 10 (2018)
       
  • Erratum. Mediterranean Diet, Retinopathy, Nephropathy, and Microvascular
           Diabetes Complications: A Post Hoc Analysis of a Randomized Trial.
           Diabetes Care 2015;38:2134-2141
    • Authors: Diaz-Lopez; A.; Babio, N.; Martinez-Gonzalez, M. A.; Corella, D.; Amor, A. J.; Fito, M.; Estruch, R.; Aros, F.; Gomez-Gracia, E.; Fiol, M.; Lapetra, J.; Serra-Majem, L.; Basora, J.; Basterra-Gortari, F. J.; Zanon-Moreno, V.; Angel Munoz, M.; Salas-Salvado, J.; the PREDIMED Study Investigators
      Pages: 2260 - 2261
      PubDate: 2018-09-20T12:00:28-07:00
      DOI: 10.2337/dc18-er10a
      Issue No: Vol. 41, No. 10 (2018)
       
  • Issues and Events
    • Pages: 2262 - 2262
      PubDate: 2018-09-20T12:00:28-07:00
      DOI: 10.2337/dc18-ie10
      Issue No: Vol. 41, No. 10 (2018)
       
 
 
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