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Browsing by Subject "Prediabetic state"
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Item Dietary Intervention for Glucose Tolerance In Teens (DIG IT): Protocol of a randomized controlled trial using health coaching to prevent youth-onset type 2 diabetes(Elsevier, 2017-02) Wagner, Kelly A.; Braun, Ethan; Armah, Seth M.; Horan, Diarmuid; Smith, Lisa G.; Pike, Julie; Tu, Wanzhu; Hamilton, Marc T.; Delp, Edward J.; Campbell, Wayne W.; Boushey, Carol J.; Hannon, Tamara S.; Gletsu-Miller, Nana; Pediatrics, School of MedicineBACKGROUND: Youth-onset type 2 diabetes (T2D) is a disease that is newly emerging and behavioral strategies for its prevention are limited. Interventions that target the lifestyle behaviors of adolescents, to improve poor dietary quality and reduce excessive sedentariness, promise to reduce the risk of developing T2D. Health coaching is effective for promoting healthy behaviors in patients who have chronic disease, but few experimental studies are in adolescents. This randomized controlled trial, in adolescents with prediabetes, will determine the effectiveness of a health coaching intervention to facilitate adoption of healthy diet and activity behaviors that delay or prevent development of T2D. METHODS/DESIGN: The Dietary Intervention for Glucose Tolerance In Teens (DIG IT) trial will involve an evaluation of a health coaching intervention in adolescents with prediabetes. Eligible participants will be randomized to receive 6months of health coaching or a single dietary consultation that is standard-of-care. The primary outcome will be 2-hour oral glucose tolerance test concentration. Secondary outcomes will include measures of glycemia and insulin action as well as dietary, physical activity and sedentary behaviors measured using an electronic food record, and by inclinometer. Data will be collected before and after the intervention (at 6months) and at 12months (to assess sustainability). DISCUSSION: This trial will determine whether a health coaching intervention, a personalized and low-cost approach to modify dietary and activity behaviors, is effective and sustainable for prevention of youth-onset T2D, relative to standard-of-care. Health coaching has the potential to be widely implemented in clinical or community settings.Item Obstructive Sleep Apnea, Glucose Tolerance, and β-Cell Function in Adults With Prediabetes or Untreated Type 2 Diabetes in the Restoring Insulin Secretion (RISE) Study(American Diabetes Association, 2021-04) Mokhlesi, Babak; Tjaden, Ashley H.; Temple, Karla A.; Edelstein, Sharon L.; Sam, Susan; Nadeau, Kristen J.; Hannon, Tamara S.; Manchanda, Shalini; Mather, Kieren J.; Kahn, Steven E.; Ehrmann, David A.; Van Cauter, Eve; RISE Consortium; Pediatrics, School of MedicineObjective: Obstructive sleep apnea (OSA) is associated with insulin resistance and has been described as a risk factor for type 2 diabetes. Whether OSA adversely impacts pancreatic islet β-cell function remains unclear. We aimed to investigate the association of OSA and short sleep duration with β-cell function in overweight/obese adults with prediabetes or recently diagnosed, treatment-naive type 2 diabetes. Research design and methods: Two hundred twenty-one adults (57.5% men, age 54.5 ± 8.7 years, BMI 35.1 ± 5.5 kg/m2) completed 1 week of wrist actigraphy and 1 night of polysomnography before undergoing a 3-h oral glucose tolerance test (OGTT) and a two-step hyperglycemic clamp. Associations of measures of OSA and actigraphy-derived sleep duration with HbA1c, OGTT-derived outcomes, and clamp-derived outcomes were evaluated with adjusted regression models. Results: Mean ± SD objective sleep duration by actigraphy was 6.6 ± 1.0 h/night. OSA, defined as an apnea-hypopnea index (AHI) of five or more events per hour, was present in 89% of the participants (20% mild, 28% moderate, 41% severe). Higher AHI was associated with higher HbA1c (P = 0.007). However, OSA severity, measured either by AHI as a continuous variable or by categories of OSA severity, and sleep duration (continuous or <6 vs. ≥6 h) were not associated with fasting glucose, 2-h glucose, insulin sensitivity, or β-cell responses. Conclusions: In this baseline cross-sectional analysis of the RISE clinical trial of adults with prediabetes or recently diagnosed, untreated type 2 diabetes, the prevalence of OSA was high. Although some measures of OSA severity were associated with HbA1c, OSA severity and sleep duration were not associated with measures of insulin sensitivity or β-cell responses.Item Predictive utilities of lipid traits, lipoprotein subfractions and other risk factors for incident diabetes: a machine learning approach in the Diabetes Prevention Program(BMJ, 2021-03) Varga, Tibor V.; Liu, Jinxi; Goldberg, Ronald B.; Chen, Guannan; Dagogo-Jack, Samuel; Lorenzo, Carlos; Mather, Kieren J.; Pi-Sunyer, Xavier; Brunak, Søren; Temprosa, Marinella; Medicine, School of MedicineIntroduction: Although various lipid and non-lipid analytes measured by nuclear magnetic resonance (NMR) spectroscopy have been associated with type 2 diabetes, a structured comparison of the ability of NMR-derived biomarkers and standard lipids to predict individual diabetes risk has not been undertaken in larger studies nor among individuals at high risk of diabetes. Research design and methods: Cumulative discriminative utilities of various groups of biomarkers including NMR lipoproteins, related non-lipid biomarkers, standard lipids, and demographic and glycemic traits were compared for short-term (3.2 years) and long-term (15 years) diabetes development in the Diabetes Prevention Program, a multiethnic, placebo-controlled, randomized controlled trial of individuals with pre-diabetes in the USA (N=2590). Logistic regression, Cox proportional hazards model and six different hyperparameter-tuned machine learning algorithms were compared. The Matthews Correlation Coefficient (MCC) was used as the primary measure of discriminative utility. Results: Models with baseline NMR analytes and their changes did not improve the discriminative utility of simpler models including standard lipids or demographic and glycemic traits. Across all algorithms, models with baseline 2-hour glucose performed the best (max MCC=0.36). Sophisticated machine learning algorithms performed similarly to logistic regression in this study. Conclusions: NMR lipoproteins and related non-lipid biomarkers were associated but did not augment discrimination of diabetes risk beyond traditional diabetes risk factors except for 2-hour glucose. Machine learning algorithms provided no meaningful improvement for discrimination compared with logistic regression, which suggests a lack of influential latent interactions among the analytes assessed in this study.Item A retrospective descriptive study of pain scores in the pre-diabetic patients on metformin(2015-07-01) Moore, Michele Nakamura; Mushi, Christina R.; Ang, Dennis C.; Mac Kinnon, Joyce L.; Sturek, Michael S.; Arnold, Brent L.Objectives: The purpose was to evaluate pain scores (SF-36 BPS) among pre-diabetic patients on metformin or placebo to determine if patients on metformin therapy report less pain (higher SF-36 BPS) than patients on placebo. Study design: A descriptive retrospective review of pain scores was conducted using secondary data analyses of the Diabetes Prevention Program (DPP) and Diabetes Prevention Program Outcomes Study (DPPOS) conducted from 1996 to 2008. Patients were randomly assigned to placebo, low (850 mg/day) or high dose (1700 mg/day) metformin groups. Pain scores using the SF-36 BPS standard version were taken before randomization and annually (year one through four). Results: Out of 3,819 patients that participated in the original study, 1,056 patients met the current study criteria. The metformin group included 506 patients and the placebo group included 550 patients. With an alpha level of 0.05 for all analyses, baseline pain scores between the metformin group and placebo group showed no significant difference. Year two showed significance between placebo and metformin pain scores (75.2 vs 78.6). All other years were not significant. Comparing low and high dose metformin and placebo groups, years one, two and three displayed significant differences in pain scores. In years one and two, the high dose metformin group reported less pain than the placebo group (80.7 vs 77.7; 80.1 vs 75.2) and the low dose metformin group (80.7 vs 71.8; 80.1 vs 68.6). In year three, the high dose metformin group had less pain than the low dose metformin group (78.4 vs 70.5).Item Sodium-glucose cotransporter 2 (SGLT2) inhibitors and non-small cell lung cancer survival(Springer Nature, 2023) Luo, Juhua; Hendryx, Michael; Dong, Yi; Medicine, School of MedicineBackground: Sodium-glucose cotransporter 2 (SGLT2) inhibitors are a relatively new class of antidiabetic drugs with demonstrated renal and cardiovascular disease benefit. This study evaluates the role of SGLT2 inhibitors on the survival of non-small cell lung cancer (NSCLC) patients. Methods: We used National Surveillance, Epidemiology and End Results (SEER)-Medicare linked data. Twenty four thousand nine hundred fifteen NSCLC patients newly diagnosed between 2014 and 2017 with pre-exiting diabetes and aged 66 years or older were included and followed to the end of 2019. Information on SGLT2 inhibitors use was extracted from the Medicare Part D file. Results: SGLT2 inhibitor use was associated with significantly reduced mortality risk after adjusting for potential confounders (HR = 0.68, 95% CI = 0.60-0.77) with stronger association for longer duration of use (HR = 0.54, 85% CI = 0.44-0.68). Further, we found that SGLT2 inhibitor use was associated with a significant reduced risk of mortality regardless of patients' demographic, tumour characteristics and cancer treatments. Conclusion: Our large SEER-Medicare linked data study indicates that SGLT2 inhibitors use was associated with improved overall survival of NSCLC patients with pre-existing diabetes. Further studies are needed to confirm our findings and elucidate the possible mechanisms behind the association.Item The Deterrence of Rapid Metabolic Decline Within 3 Months After Teplizumab Treatment in Individuals at High Risk for Type 1 Diabetes(American Diabetes Association, 2021) Sims, Emily K.; Cuthbertson, David; Herold, Kevan C.; Sosenko, Jay M.; Pediatrics, School of MedicineEnd points that provide an early identification of treatment effects are needed to implement type 1 diabetes prevention trials more efficiently. To this end, we assessed whether metabolic end points can be used to detect a teplizumab effect on rapid β-cell decline within 3 months after treatment in high-risk individuals in the TrialNet teplizumab trial. Glucose and C-peptide response curves (GCRCs) were constructed by plotting mean glucose and C-peptide values from 2-h oral glucose tolerance tests on a two-dimensional grid. Groups were compared visually for changes in GCRC shape and movement. GCRC changes reflected marked metabolic deterioration in the placebo group within 3 months of randomization. By 6 months, GCRCs resembled typical GCRCs at diagnosis. In contrast, GCRC changes in the teplizumab group suggested metabolic improvement. Quantitative comparisons, including two novel metabolic end points that indicate GCRC changes, the within-quadrant end point and the ordinal directional end point, were consistent with visual impressions of an appreciable treatment effect at the 3- and 6-month time points. In conclusion, an analytic approach combining visual evidence with novel end points demonstrated that teplizumab delays rapid metabolic decline and improves the metabolic state within 3 months after treatment; this effect extends for at least 6 months.