bluuebunny/crossref_metadata_2025 huggingface dataset:
716-P: Addressing Barriers to Diabetes Education and Care in Low Socioeconomic Latinos in Georgia
Authors: SONYA HAW J. , FLORES INA CECILIA , PORRAS FIMBRES DENISSE CRISTINA , ROTBERG BRITT , MIGDAL ALEXANDRA , WANG HEQIONG , PASQUEL FRANCISCO J. , UMPIERREZ GUILLERMO E.
Published: June 2019

Latinos have higher rates of type 2 diabetes, worse glycemic control, and higher rates of diabetic complications than other ethnic groups. The Emory Latino Diabetes Education Program (ELDEP) is a non-profit DSME program that provides free Spanish diabetes education and lifestyle intervention for Latinos with diabetes in Georgia. We present our experience with ELDEP and describe barriers to diabetes care.

Results: A total of 1680 patients attended our program between 2006 and 2018. All subjects were foreign-born and most came from Mexico (71%). Their average age was 48±12 years, female: 63%, BMI: 31±7 kg/m2, 26% with more than 10 years of DM and the majority were not treated with medications (58%). A total of 297 (17.7%) patients returned for at least one follow-up class within 6 months. Most patients who returned were female (67%). The mean HbA1c at presentation was 8.9±2.6%, 7.7±2.0% at 3 months, and 7.4±1.3% at 6 months of follow-up. Compared to women, men had a larger reduction in HbA1c from baseline -1.6±3.0% vs. -0.9±2.1% at 3 months and -2.4±2.9% vs. -1.2±1.8% at 6 months follow-up (p=0.07). Major barriers to care identified: i) low literacy: 36% of patients did not read or write Spanish; ii) poor language proficiency: 87% did not speak, read, or write English; iii) low education level: 19% high school, and 6% college education; iv) low health insurance coverage: 76% had no health insurance, 9% had Medicare or Medicaid, and 8% had private insurance; v) financial: 63% have annual household income < $20,000 and most had severe financial limitations in buying prescribed diabetes regimen; vi) 41% had food insecurity and 47% consumed less than the recommended vegetable intake; and vii) 94% had a low level of acculturation.

Conclusions: Our results identify important cultural and socio-economic challenges to diabetes care faced by Latinos in Georgia. The ELDEP is a successful and easy-to-implement education model that addresses some of these challenges to improve diabetes care in the underserved Latino population.

Disclosure

J. Haw: None. I.C. Flores: None. D. Porras Fimbres: None. B. Rotberg: Employee; Self; Insulet Corporation, Novo Nordisk A/S. A. Migdal: None. H. Wang: None. F.J. Pasquel: Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Merck & Co., Inc. G.E. Umpierrez: Advisory Panel; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc. Research Support; Self; AstraZeneca, Merck & Co., Inc., Novo Nordisk Inc., Sanofi US.

Funding

Sanofi
72-OR: Clinical Burden and Impact of New-Onset Diabetic Foot Ulcers, Post-Simultaneous Pancreas Kidney Transplantation, and Kidney Only Transplantation
Authors: SHARMA ANGELICA , FOUNTOULAKIS NIKOLAOS , VAS PRASH R. , KARALLIEDDE JANAKA
Published: June 2019

Background: Patients with diabetes and renal dysfunction are at risk of diabetic foot ulcers (DFU). Whether this risk is modified post simultaneous pancreas-kidney (SPK) or kidney only (KO) transplant is unknown.

Aims: We evaluated the incidence of new onset DFU post SPK and KO transplant performed between 2004 and 2014 in 234 patients with diabetic kidney disease.

Methods: In total 90 (51% male) SPK patients and 144 KO (66% male, 26% type 1 DM) were evaluated in a single centre retrospective study. Median (range) follow-up was 6 (3 to 13) years for both cohorts.

Results: We observed that 16 (17%) of SPK and 22 (15%) KO patients respectively developed a new DFU during follow-up. Nearly 60% of new onset DFU presented within 500 days post SPK transplant. In KO cohort more than 50% of DFU presented within 1000 days post kidney transplant. In both cohorts a history of peripheral vascular disease (PVD) [37.5% vs. 4%] and pre-transplant history of DFU were associated with post transplant DFU p<0.05. In KO cohort, patients who developed a DFU were more likely to have T1DM than T2DM (29% vs. 10%), and had higher pre-transplant HbA1c, (mean ± standard deviation [7.5 ±1.2% vs. 6.8±1.4%, p<0.05]). There was no impact of DFU on SPK transplant failure. In contrast patients with DFU post KO transplant had more than five fold increased hazard ratio (HR) of transplant failure as compared to those without DFU independent of other risk factors [HR 5.19 95% CI (2.05 to 13.18) p=0.001].

Conclusion: There is a residual high burden of new onset DFU post KO or SPK transplantation. Our results highlight the need for greater awareness of regular foot examination, DFU prevention and risk evaluation in post-transplant patients.

Disclosure

A. Sharma: None. N. Fountoulakis: None. P.R. Vas: Other Relationship; Self; Sanofi-Aventis. J. Karalliedde: Research Support; Self; AstraZeneca, Sanofi. Speaker's Bureau; Self; AstraZeneca, Boehringer Ingelheim International GmbH, NAPP Pharmaceuticals Limited.
720-P: Exercise Training Causes Vast Changes in the Circulating Factor Profile of Human Subjects
Authors: MIDDELBEEK ROELAND , RICHARD JEFFREY J. , ROWLAND LESLIE A. , NIGRO PASQUALE , PAN HUI , DREYFUSS JONATHAN , GOODYEAR LAURIE J.
Published: June 2019

Exercise training induces adaptations to the body that improve metabolic health; however, the molecular mechanisms mediating these beneficial adaptations to training are not well characterized. We hypothesized that exercise training causes adaptations to multiple tissues (e.g., muscle, adipose) that lead to altered secretion of factors from these tissues into the circulation, and that these circulating factors may contribute to the effects of exercise training on metabolic health. To identify novel exercise training-stimulated circulating factors, healthy subjects (n=8, 3 males and 5 females; age=27.0 ± 2.2 years; BMI=21.9 ± 0.9 kg/m2; V?O2peak=28.4 ± 1.2 ml/kg/minute) underwent 10-weeks of aerobic exercise training. Training increased V?O2peak by 17% (p=<0.003). Fasting blood samples were collected pre- and post-training, and 1,310 circulating factors were measured in plasma using aptamer-based proteomics. Remarkably, exercise training significantly altered 293 (22%) of all circulating factors. 164 proteins were increased and 129 proteins were decreased; the majority of which have not been previously identified as exercise training-induced factors. Change in V?O2peak most significantly correlated with baseline levels of Mesothelin (p<0.001, R=0.53), a cell-surface protein that may regulate Insulin-like Growth Factor transport. Change in V?O2peak was also highly correlated with Protein Kinase C Zeta (p=0.005, R=0.3), a kinase involved in AKT3-PI3K signaling and adipocyte glucose transport. Pathway analysis revealed downregulation of the lysosomal pathway, and upregulation of pathways including FC Epsilon Ri signaling, Mtor signaling and WNT signaling, suggesting that exercise training adaptations involve multiple processes, including cellular growth, proliferation and protein degradation. These data define proteomic adaptations to exercise training, and identify biological processes that may mediate the beneficial effects of exercise training in humans.

Disclosure

R. Middelbeek: None. J.J. Richard: None. L.A. Rowland: None. P. Nigro: None. H. Pan: None. J. Dreyfuss: None. L.J. Goodyear: None.

Funding

National Institutes of Health (R01DK099511 to L.J.G.), (K23DK114550 to R.M.); Joslin Diabetes Center (5P30DK36836); Daiichi Sankyo (to L.J.G.); Boston Area Diabetes Endocrinology Research Center (to R.M.)
722-P: Maternal Exercise Improves Metabolic Health of Grand-Offspring
Authors: WAGNER ANA B.A. , KUSUYAMA JOJI , NIGRO PASQUALE , HIRSHMAN MICHAEL F. , GOODYEAR LAURIE J.
Published: June 2019

Maternal environments are critical factors in determining risk for obesity and diabetes in both first generation (F1) and second generation (F2) offspring. Maternal exercise in mice has been shown to improve metabolic health in F1, including prevention of the detrimental effects of maternal high-fat feeding on F1 offspring. Whether the beneficial effects of maternal exercise can be transmitted to the F2 generation (grand-offspring) is not known. To test this, C57BL/6 females were fed a chow or high fat diet (60% fat) and grouped by housing in cages with (Exercise Trained) or without (Sedentary) running wheels for 2 weeks before breeding (7.04±0.5 km/day) and during gestation (2.2±0.3 km/day). Females were bred with chow-fed, sedentary males. F1 offspring were sedentary and chow-fed. At 8 weeks of age, two male mice (F1) from each litter (selected based on average body weight of the litter), were bred with age-matched female mice from untreated parents. Thus, four groups of F2 offspring resulted based on grand-maternal treatment: sedentary and chow-fed; sedentary and high fat-fed; trained and chow-fed; trained and high fat-fed (n=5-10 litters/group). F2 offspring were sedentary and chow-fed post-weaning. Unexpectedly, there was no effect of grand-maternal high fat diet on F2 glucose tolerance at any age. There was also no effect of grand-maternal exercise on glucose tolerance in offspring at 16 or 24 weeks of age. However, grand-maternal exercise resulted in a tendency for improvement in glucose tolerance in 36-week-old offspring (P=0.07), and a significant improvement at 52 weeks (males: P=0.03; females: P=0.0001). Male and female body weights were not different among F2 groups. F2 offspring from exercise-trained grand-mothers had decreased % fat mass (males: P=0.04; females: P=0.05) and increased % lean mass in males (P=0.04), with a tendency to increase in females (P=0.06) at 52 weeks of age.

In conclusion, grand-maternal exercise training has beneficial effects in the metabolic health of adult male and female F2 offspring.

Disclosure

A.B.A. Wagner: None. J. Kusuyama: None. P. Nigro: None. M.F. Hirshman: Stock/Shareholder; Self; Abbott Laboratories, AbbVie Inc., Amgen Inc., Colgate-Palmolive Company, Medtronic. L.J. Goodyear: None.

Funding

American Diabetes Association (1-17-PMF-009 to A.B.A.W.); National Institutes of Health (R01DK101043)
73-LB: Improvements in Sleep Quality after Cognitive Behavioral Therapy for Insomnia Are Associated with Improved 2-Hour Post-Load Glucose
Authors: LEBLANC ERIN S. , SMITH NING , ALLISON MICHAEL , CLARKE GREG
Published: June 2019

Poor-quality sleep may be a possible modifiable risk factor in the development of T2DM. We conducted a pilot clinical trial (N=17) to examine the effects of insomnia treatment on insulin resistance in persons with prediabetes. Participants received up to 7 sessions of cognitive behavioral therapy for insomnia (CBT-I), a highly effective, first-line treatment for insomnia. Before and after CBT-I, participants underwent 75-gram oral glucose load test and wore wrist Actiwatches (ActiGraph GT9X Link) to measure sleep indices. Actigraphy data were collected, including wake after sleep onset (WASO; length of periods of wakefulness after sleep onset) and sleep efficiency (SE; ratio of time asleep to time in bed). We calculated the correlation between change in 2-hour post-load glucose and change in WASO and SE in those who completed treatment (at least 6 sessions of CBT-I; N=13). Decreases in WASO and increases in SE after CBT-I (indicating improved sleep) were associated with decreased 2-hour post load glucose levels (see Figure). The estimated Pearson correlations indicated medium-large effect sizes per Cohen’s rule, suggesting a potential reduction in the risk of full T2DM. This small pilot study shows the need for further research on whether treatment of insomnia improves glucose tolerance.

Disclosure

E.S. LeBlanc: None. N. Smith: None. M. Allison: None. G. Clarke: None.

Funding

Kaiser Permanente
733-P: Circulating Vaspin Level Was Changed with Endothelial Function, but Not with Visceral or Ectopic Fat during Lifestyle Modification in Korean Type 2 Diabetes
Authors: HAN KYUNG AH , MIN KYUNGWAN
Published: June 2019

Vaspin is an adipocytokine identified in visceral adipose tissues and has anti-inflammatory effects in vascular smooth muscle cells. We investigated the association between visceral or ectopic adiposity, insulin resistance, inflammatory markers and endothelial function including circulating vaspin, and the effects of lifestyle modification in Korean type 2 diabetes. Total 170 overweight women with type 2 diabetes (age 55.0±7.6 years; BMI 27.4±2.8 kg/m2) were randomly assigned to control (C), diet (D), aerobic exercise (AE) and resistance exercise (RE) and 82 completed the weight loss program for 12 weeks. We assessed BMI, total abdominal (TAF), visceral fat (VAF), liver and spleen attenuation ratio (LSR), and intramuscular adipose tissue (IMAT) at midthigh level using computed tomography, and FMD (Flow-mediated dilation), vaspin, adiponectin/leptin ratio (ALR), free fatty acid (FFA), hsCRP, and insulin sensitivity by homeostatic model assessment insulin resistance (HOMA-IR) at baseline, and 12 week. The log transformed variables are prefixed by 'ln' BMI decreased by 7.07% in RE, 6.42% in D and 3.28% in AE (p<0.001 vs. control). TAF and VAF also decreased by 18.82% and 22.06% in RE, 11.96% and 14.12% in D, 8.30%and 8.38% in D (consecutively, p<0.001 vs. control). ALR was increased comparably in 3 intervention groups. Percent changes (pc) of vaspin, FFA, hsCRP, HOMA IR, FMD, IMAT, LSR were not different among 4 groups. Within group analysis, vaspin was increased from 0.74 to 1.04 (p=0.096) in AE, FMD was increased in D and AE (p<0.001, P=0.035). Crushed the groups, ln-vaspin pc was changed with ln-FMD pc (r=-0.246, p=0.016), but not with pc of ln-VAF, IMAT. Total fat was changed with ALR (r=-0.151, p=0.042). LSR with hsCRP (r=-0.217, p=0.038). These findings suggested that the circulating vaspin level was more related with vascular function rather than regional or ectopic adiposity during lifestyle modification in type 2 diabetes.

Disclosure

K. Han: None. K. Min: None.
736-P: Two Years Moderate Resistance Training Prevents Type 2 Diabetes but Does Not Reduce Cardiovascular Risk for Patients with Prediabetes
Authors: LOU QINGQING
Published: June 2019

Resistance training can decrease blood glucose, reduce fat volume and increase muscle mass, but whether long term resistance training can prevent type 2 diabetes and reduce cardiovascular risk or not remains unclear.

248 prediabetes patients enrolled in this multicentered RCT study were randomized in to 3 groups: resistance training (RT, n=82), aerobic training (AT, n=83), and control group (n=83). The participants in RT and AT groups did moderate RT or AT 3 times a week (150minutes/week) with supervision in 3 research centers for 2 years.

Compared to the control group, participants in both RT group and AT group experienced a significant reduction in A1c at month 6, 12 and 24. After adjusted for age, sex, BMI, and statin use, Resistance training and aerobic training reduced type 2 diabetes risk by 58.2% (p=0.028) and 73.2% (p=0.004), respectively, but neither AT nor RT reduced cardiovascular risk (Framingham Score). In terms of remission to normal glucose tolerance (NGT), RT and AT increased the RR by 7.84 (p=0.008) and 6.68 (p=0.016), respectively.

The results of this study demonstrated that 2 years moderate resistance training has comparable effects on preventing type 2 diabetes and reversing to NGT for patients with prediabetes.

Disclosure

Q. Lou: None.
741-P: More Time-in-Range during Days with Structured Exercise vs. Sedentary Days in Adults with Type 1 Diabetes
Authors: RIDDELL MICHAEL , LI ZOEY , BECK ROY , GAL ROBIN L. , JACOBS PETER G. , CASTLE JESSICA R. , GILLINGHAM MELANIE B. , CLEMENTS MARK A. , PATTON SUSANA R. , DASSAU EYAL , DOYLE FRANCIS J. , MARTIN CORBY K. , CALHOUN PETER , RICKELS MICHAEL R.
Published: June 2019

Structured exercise can help patients with type 1 diabetes (T1D) achieve physical activity targets, however the effects of exercise type on percent time in range (TIR) and glucose variability are unclear. The Type 1 Diabetes Exercise Initiative Pilot Study provided the opportunity to examine glycemic control on structured exercise days compared to sedentary days. Adults with T1D ([mean ± SD] age= 32 ± 14 years; HbA1C= 7.8 ± 1.6%), using a continuous glucose monitor, were assigned to complete twice weekly aerobic, interval or resistance exercise sessions, using study-developed instructional videos for a period of 4 weeks. TIR was higher (Figure 1) and mean glucose concentration was lower overall on exercise days compared with sedentary days (160 ± 52 vs. 176 ± 49 mg/dL, P<0.001). Glucose variability was similar between exercise and sedentary days (coefficient of variation: 36 ± 12% vs. 37% ± 12%).

In summary, participants had lower 24-hour mean glucose levels and a greater percent time in range on active days compared with inactive days.

Disclosure

M. Riddell: Advisory Panel; Self; Xeris Pharmaceuticals, Inc. Research Support; Self; Dexcom, Inc. Speaker's Bureau; Self; Insulet Corporation, Medtronic MiniMed, Inc. Stock/Shareholder; Self; Zucara Therapeutics Inc. Z. Li: None. R. Beck: Other Relationship; Self; Abbott Laboratories, Ascensia Diabetes Care, Bigfoot Biomedical, Dexcom, Inc., Insulet Corporation, Lilly Diabetes, Roche Diabetes Care, Tandem Diabetes Care. R.L. Gal: None. P.G. Jacobs: Stock/Shareholder; Self; Pacific Diabetes Technologies. J.R. Castle: Advisory Panel; Self; Novo Nordisk Inc., Zealand Pharma A/S. Consultant; Self; Dexcom, Inc. Research Support; Self; Dexcom, Inc., Xeris Pharmaceuticals, Inc. M.B. Gillingham: None. M.A. Clements: Advisory Panel; Self; Glooko, Inc. Consultant; Self; Eli Lilly and Company. Speaker's Bureau; Self; Medtronic. S.R. Patton: None. E. Dassau: Consultant; Self; Eli Lilly and Company, Insulet Corporation. Research Support; Self; Dexcom, Inc., DreaMed Diabetes, Ltd., Insulet Corporation, Roche Diabetes Care, Tandem Diabetes Care, Xeris Pharmaceuticals, Inc. Speaker's Bureau; Self; Roche Diabetes Care. Other Relationship; Self; ModAGC. F.J. Doyle: Consultant; Self; ModeAGC. Other Relationship; Self; Insulet Corporation. C.K. Martin: Advisory Panel; Self; EHE. Consultant; Self; ACAP Health, Florida Hospital, WW, Zafgen, Inc. Other Relationship; Self; Academy of Nutrition and Dietetics. P. Calhoun: Stock/Shareholder; Self; Dexcom, Inc. M.R. Rickels: None.

Funding

The Leona M. and Harry B. Helmsley Charitable Trust
742-P: Magnitude of A1C Improvement in Relation to Weight Loss after Intensive Lifestyle Intervention in Real-World Diabetes Practice: Thirteen Years of Observation
Authors: ELDIB AHMED H. , TOMAH SHAHEEN , MOTTALIB ADHAM , ASHRAFZADEH SAHAR , HAMDY OSAMA
Published: June 2019

The effect of intensive lifestyle intervention (ILI) on A1C in real-world clinical practice is inconsistent and is frequently underestimated. It is also presumed that the magnitude of A1C improvement is solely dependent on the amount of weight loss. In this study we report the magnitude of A1C change in a large cohort of patients with diabetes who underwent ILI over 13 years in relation to their baseline A1C and the amount of weight loss.

We evaluated 590 diabetic patients (age 52.5±11 years, 58.6% females, A1C 7.7±1.4%, weight 105.54±18.6 Kg, BMI 36.7±5.1 Kg/m2, diabetes duration 10.9±9.8 years, 83.7% with type 2 diabetes), who enrolled in the Weight Achievement and Intensive Treatment (Why WAIT) program, a 12-week multidisciplinary ILI designed for real-world clinical practice between September 2005 and May 2018. We stratified patients based on baseline A1C into three groups: group A with A1C 9% (16.95% of participants), group B with A1C from 8 to <9% (19.15% of participants), and group C with A1C <8% (63.9% of participants). After 12 weeks of intervention, body weight decreased by 8.5±4.6 Kg in group A, 8.0±4.6 Kg in group B, and 7.6±5.8 Kg in group C (p=0.22 between groups). A1C decreased by 2.5±1.3% in group A, 1.2±0.8% in group B and 0.5±0.6% in group C (p<0.001 between groups). Pairwise comparisons of A1C changes between groups showed that: group A had 1.3% greater A1C reduction than group B (p=0.0001) and 2% greater A1C reduction than group C (p=0.0001), while group B had 0.7% greater A1C reduction than group C (p=0.0001).

Conclusion: ILI may decrease A1C by up to 2.5% in patients with diabetes. In patients with a similar magnitude of weight loss, A1C reduction was more prominent in those with higher baseline A1C levels. This may be valuable for clinicians to set realistic expectations of A1C reduction for their patients in response to ILI, which is usually the primary step in diabetes management.

Disclosure

A.H. Eldib: None. S. Tomah: Stock/Shareholder; Self; Amarin Corporation. A. Mottalib: None. S. Ashrafzadeh: None. O. Hamdy: Advisory Panel; Self; AstraZeneca, Sanofi-Aventis. Consultant; Self; Abbott, Merck & Co., Inc. Research Support; Self; National Dairy Council. Stock/Shareholder; Self; Healthimation, LLC.
743-P: New Insulin Algorithm Reduces Carbohydrate (CHO) Requirements during Prolonged Outdoor Exercise
Authors: MUELLER-KORBSCH MICHAEL , FRÜHWALD LISA , HEER MICHAEL , FANGMEYER-BINDER MARIA , REINHART-MIKOCKI DAVID
Published: June 2019

Individuals with T1D are generally advised to reduce basal rates and increase CHO intake during aerobic exercise. We assessed the effects of a different insulin regimen guided by rtCGM data on CHO intake and glucose levels in 17 T1D adults treated with insulin pumps (11 male, 42±8.8 years, 24±10 years DM duration, 6.6±0.8% A1C) vs. traditional insulin adjustment guidance during 2 consecutive days of extended biking activities (30 miles [49 km]). On day 1 (D1), subjects reduced their basal rate by 50% and consumed CHO as guided by their rtCGM (Dexcom G6) data to maintain target range (70-180 mg/dL). Basal insulin infusion was stopped 1 hour at the start of the day 2 activity (D2) then resumed at a minimal rate (0.23±0,1U/hour) during biking. All CHO from 1 hour before, during and 10 min after the activity was recorded. Times within/below target range, glycemic variability (GV) and mean glucose were calculated from rtCGM data. CHO intake was notably lower during D2 vs. D1 (36±32 vs. 40±27 g, p=NS), with slightly more time in range and <70 mg/dL but no difference in time <54 mg/dL (both p=NS). (Figure 1) Significant reductions in GV (34±7 vs. 47±13 mg/dL, p<0.01) and slight reductions in mean glucose (124±24 vs. 110±14 mg/dL, p=NS) were seen. No severe hypoglycemic events occurred. T1D individuals using rtCGM in conjunction with insulin pump therapy can safely reduce their CHO requirements during prolonged exercise using the new algorithm.

Disclosure

M. Mueller-Korbsch: Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Menarini Group, Novo Nordisk Inc. L. Frühwald: None. M. Heer: None. M. Fangmeyer-Binder: None. D. Reinhart-Mikocki: None.
750-P: Oral Carbohydrate Demand during Endurance Exercise Is Dependent on Pre-exercise Blood Glucose Concentration in People with Type 1 Diabetes: A Randomized Crossover Trial
Authors: ECKSTEIN MAX L. , MOSER OTHMAR , MUELLER ALEXANDER , BIRNBAUMER PHILIPP , ABERER FELIX , KOEHLER GERD , SOURIJ CAREN , KOJZAR HARALD , PFERSCHY PETER N. , DIETZ PAVEL , BRACKEN RICHARD M. , HOFMANN PETER , SOURIJ HARALD
Published: June 2019

Aim: To investigate the impact of moderate-intensity exercise and pre-exercise blood glucose concentrations (BG) on the demand of orally administered carbohydrates (CHO) to maintain euglycemia (> 70 - 180 mg/dL) during endurance exercise sessions performed over 5 consecutive days on either a regular (100%) or reduced dose (75%) of insulin degludec (IDeg) in people with type 1 diabetes (T1D).

Methods: Nine participants with T1D (four women, mean age 32.1 ± 9.0 years, BMI 25.5 ± 3.9 kg/m2, glycated hemoglobin 55 ± 7 mmol/mol [7.2 ± 0.6%]) on IDeg were randomized to cycle for 55 minutes at moderate intensity (63 ± 7% VO2max) for 5 consecutive days on either 100% or 75% of their regular IDeg dose. The exercise accumulating effect was analysed via one-way-ANOVA for repeated measures (day x administered CHO). The influence of pre-exercise BG was analysed by one-way ANOVA or Kruskal-Wallis stratified for BG quartiles and Spearman correlation. The effect of IDeg dose (100% vs. 75%) on given CHO was calculated via Wilcoxon or student's t-test (p<0.05).

Results: No exercise accumulating effect was found (p>0.05) but CHO intake was significantly related to pre-exercise BG (r=-0.45; p<0.0001).

Conclusion: Pre-exercise BG had a significant influence on the demand of orally administered CHO to maintain euglycemia during exercise over 5 consecutive days.

Disclosure

M.L. Eckstein: Research Support; Self; Novo Nordisk A/S. O. Moser: Research Support; Self; Abbott, Dexcom, Inc., Novo Nordisk A/S. A. Mueller: None. P. Birnbaumer: None. F. Aberer: None. G. Koehler: Advisory Panel; Self; Boehringer Ingelheim International GmbH, Lilly Diabetes, Novo Nordisk A/S. Speaker's Bureau; Self; Boehringer Ingelheim International GmbH, Lilly Diabetes, Novo Nordisk A/S, Sanofi-Aventis Deutschland GmbH. C. Sourij: None. H. Kojzar: None. P.N. Pferschy: None. P. Dietz: None. R.M. Bracken: None. P. Hofmann: None. H. Sourij: Advisory Panel; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi-Aventis. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novo Nordisk A/S, Novo Nordisk A/S, Sanofi-Aventis. Speaker’s Bureau; Self; Amgen Inc., AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi-Aventis.

Funding

Novo Nordisk Pharma GmbH
752-P: Japanese Radio Calisthenics Prevents Reduction of Skeletal Muscle Volume in Patients with Type 2 Diabetes
Authors: KIMURA TOMONORI , OKAMURA TAKURO , HASHIMOTO YOSHITAKA , SENMARU TAKAFUMI , USHIGOME EMI , HAMAGUCHI MASAHIDE , ASANO MAI , YAMAZAKI MASAHIRO , FUKUI MICHIAKI
Published: June 2019

Patients with type 2 diabetes often suffer from reduction in muscle mass and strength. Recent studies reported that high-intensity resistance training improves physical function, however, it was difficult for all patients to perform that. Radio calisthenics, which has been considered as a therapeutic exercise to promote health in Japan, is a simple exercise that can be done regardless of age and can move the muscles and joints effectively according to the rhythm of radio. Here we investigated the impact of Radio calisthenics for muscle mass in patients with type 2 diabetes. A total of 42 patients whom hospitalized in the Kyoto Prefectural University of Medicine were recruited. Skeletal muscle index (SMI) was defined as appendicular muscle mass(kg) divided by the square of the height (m). Change of SMI means the difference of SMI between the end and beginning of the hospitalization. Among 42 patients, 15 patients (11 males and 4 females) performed the Radio calisthenics. The change of SMI in Radio calisthenics exercisers was significantly lower than that in non-exercisers (-0.008±0.085 vs. -0.273±0.063, p=0.016). Radio calisthenics was positively associated with the change of SMI (standardized partial coefficient, beta = 0.395, p= 0.039) (Table). Radio calisthenics prevents the reduction of skeletal muscle mass and it could be one of the effective exercises for patients with type 2 diabetes.

Disclosure

T. Kimura: None. T. Okamura: None. Y. Hashimoto: Research Support; Self; Asahi Kasei Pharma. T. Senmaru: None. E. Ushigome: Speaker's Bureau; Self; Astellas Pharma Inc., AstraZeneca, Daiichi Sankyo Company, Limited, Johnson & Johnson, Kyowa Hakko Kirin Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Novo Nordisk Inc., Sumitomo Dainippon Pharma Co., Ltd., Takeda Pharmaceutical Company Limited. M. Hamaguchi: None. M. Asano: None. M. Yamazaki: None. M. Fukui: Research Support; Self; Astellas Pharma Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Daiichi Sankyo Company, Limited, Eli Lilly and Company, Johnson & Johnson, Kyowa Hakko Kirin Co., Ltd., Merck & Co., Inc., Mitsubishi Tanabe Pharma Corporation, Novo Nordisk Inc., Ono Pharmaceutical Co., Ltd., Sanofi, Sanwa Kagaku Kenkyusho, Takeda Pharmaceutical Company Limited. Speaker's Bureau; Self; AstraZeneca, Eli Lilly and Company, Kowa Pharmaceutical Europe Co. Ltd., Kyowa Hakko Kirin Co., Ltd., Merck & Co., Inc., Mitsubishi Tanabe Pharma Corporation, Novo Nordisk Inc., Ono Pharmaceutical Co., Ltd., Sanofi, Sanwa Kagaku Kenkyusho, Taisho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company Limited.
753-P: Protein vs. Carbohydrate in Gestational Diabetes
Authors: TROUT KIMBERLY K. , COMPHER CHARLENE , DURNWALD CELESTE P.
Published: June 2019

Purpose/Aim: There has been little exploration on the effect of varied dietary intake on glycemic control in women with gestational diabetes (GDM). We evaluated the effects of diet with varying protein (Pro) and carbohydrate (CHO) with fat held constant on maternal glucose levels.

Methods: A random order cross over design was used in women diagnosed with GDM between 28-35 weeks gestation by Carpenter and Coustan criteria who were diet controlled for 3-10 days on standard GDM diet. In random order, women admitted to the research unit were allocated to one of two diets (30% kcal as Protein/35% kcal as CHO versus 15% Pro/50% CHO) using standardized meals and snacks and crossed over to the other diet treatment after a 3-7 day washout period. Maternal glucose was measured at 30” intervals post-meal via YSI analysis during 2 overnight admissions with weighed and measured meals and snacks provided.

Results: Twelve women were enrolled, 7 African-American; 3 non-Hispanic white; 1 Asian;1 Hispanic. Mean age= 33.9±5.4 years, pre-pregnancy BMI=28.7±5.3. At day 2 breakfast, mean glucose values were lower in the 30%Pro/35%CHO arm after 30 and 60” (90.7 vs. 101.6 mg/dL and 109.8 vs. 120.9 mg/dL), and 3-hour post-breakfast AUC was lower (17395.20 ±2493.47 vs. 19172.47 ±3484.31, p=0.01). The 3-hour post-lunch AUC was also lower in the 30% Pro/35% CHO arm (14365.81 ±1502.61 vs. 15077.30 ±2179.03, p<0.03).

Discussion: The higher protein/lower carbohydrate dietary strategy ameliorated the expected post-prandial rise in glucose in these women with GDM and was well-tolerated by all subjects. Longer term outcomes of such an approach, including both maternal glycemic control, nitrogen balance and fetal growth outcomes are needed.

Disclosure

K.K. Trout: None. C. Compher: None. C.P. Durnwald: None.

Funding

National Institutes of Health
756-P: Changes in Gut Microbiota in Response to a Plant-Based Diet Are Related to Changes in Weight, Body Composition, and Insulin Sensitivity: A 16-Week Randomized Clinical Trial
Authors: KAHLEOVA HANA , TURA ANDREA , BARNARD NEAL
Published: June 2019

Background: This study tested the effect of a 16-week plant-based diet on gut microbiota composition, body weight, body composition, and insulin resistance in overweight adults with no history of diabetes.

Methods: Participants (n=148) were randomized to follow a low-fat vegan diet (n=73) or to make no diet changes (n=75) for 16 weeks. At baseline and 16 weeks, gut microbiota composition was assessed, using uBiome kits. Dual energy X-ray absorptiometry was used to measure body composition. PREDIM index was used to assess insulin sensitivity. Repeated measure ANOVA was used for statistical analysis.

Results: Body weight was reduced significantly in the vegan group (treatment effect -5.8 kg [95% CI, -6.9 to -4.7 kg]; p<0.001), particularly due to a reduction in fat mass (treatment effect -3.9 kg [95% CI, -4.6 to -3.1 kg]; p<0.001) and in visceral fat (treatment effect -172 cm3 [95% CI, -308 to -37 kg]; p=0.01). PREDIM increased significantly (p<0.001) in the vegan group (treatment effect +0.88 [95% CI, +0.5 to +1.2]; p<0.001). The relative abundance of Faecalibacterium prausnitzii increased in the vegan group (treatment effect +4.8% [95% CI, +1.97 to +7.58%]; p=0.001). Relative changes in Faecalibacterium prausnitzii correlated negatively with changes in body weight (r=-0.26; p=0.008), fat mass (r=-0.26; p=0.008), and visceral fat (r=-0.25; p=0.01). The relative abundance of Bacteoides fragilis increased in the vegan group (treatment effect +19.5% [95% CI, +14.7 to +24.3%]; p<0.001). Relative changes in Bacteroides Fragilis correlated negatively with changes in body weight (r=-0.48; p<0.001), fat mass (r=-0.48; p<0.001), visceral fat (r=-0.24; p=0.02), and positively with changes in PREDIM (r=0.36; p=0.0004).

Conclusions: A 16-week low-fat vegan dietary intervention induced changes in gut microbiota that were related to changes in weight, body composition and insulin sensitivity in overweight adults.

Disclosure

H. Kahleova: None. A. Tura: None. N. Barnard: None.

Funding

Physicians Committee for Responsible Medicine
764-P: Low Dietary Energy Density (DED) Diet Is Associated with Favorable Dietary Pattern in Japanese Patients with Type 2 Diabetes (T2DM)
Authors: TAKEDA YASUNAGA , FUJIHARA KAZUYA , HATTA MARIKO , MORIKAWA SAKIKO Y. , HORIKAWA CHIKA , ISHII DAI , NEDACHI RINA , MAEGAWA HIROSHI , SONE HIROHITO ,   JDDM STUDY GROUP
Published: June 2019

Dietary energy density (DED) is receiving increased attention reflecting recent reports of inverse associations with health outcomes. Although high DED meals are reportedly associated with low diet quality in the general population, such evidence in patients with diabetes is sparse, which led us clarify this issue in Japanese patients with T2DM. Analyzed were 1,615 outpatients with T2DM (men 62.2%) who attended 24 clinics specializing in diabetes care nationwide. Dietary habits were obtained using a food frequency questionnaire (FFQg) based on 18 food groups. DED (kcal/g) was calculated by dividing EI (kcal) from foods (excluding beverages) by weights of these foods (g). Mean DED (±SD) was 1.53±0.23 (kcal/g). Typical dietary patterns comprised of some significant food groups were extracted by principal component analysis. Pearson's correlation analysis was used to evaluate the associations between identified food patterns and DED. We could extract and validate three dietary patterns, which we labeled as “Healthy,” “Western,” and “Animal foods and confectionery.” Two patterns were significantly correlated with DED (Healthy: r=-0.48, Animal foods and confectionery: r=-0.69). A multivariate linear regression model was used to determine food groups that were independently related to DED. DED was positively associated with confectioneries (standardized β=0.19, P<0.001), bread (0.10, P<0.001), and fat and oil (0.09, P<0.001). On the contrary, DED was negatively associated with brightly colored vegetables (-0.25, P<0.001), fruits (-0.31, P<0.001), and light-colored vegetables (-0.43, P<0.001).

In conclusion, lower DED, which is related to higher intakes of vegetables and fruits was associated with a healthy diet pattern in T2DM patients. DED is a useful indicator of diet quality and could be utilized in nutritional education for people with T2DM.

Disclosure

Y. Takeda: None. K. Fujihara: None. M. Hatta: None. S.Y. Morikawa: None. C. Horikawa: None. D. Ishii: None. R. Nedachi: None. H. Maegawa: Research Support; Self; Antares Pharma, Boehringer Ingelheim Pharmaceuticals, Inc., Daiichi Sankyo Company, Limited, Mitsubishi Tanabe Pharma Corporation, Takeda Pharmaceutical Company Limited. Speaker's Bureau; Self; Astellas Pharma Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Daiichi Sankyo Company, Limited, Merck Sharp & Dohme Corp., Mitsubishi Tanabe Pharma Corporation, Takeda Pharmaceutical Company Limited. H. Sone: Research Support; Self; Astellas Pharma Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Daiichi Sankyo Company, Limited, Kowa Pharmaceutical Europe Co. Ltd., Kyowa Hakko Kirin Co., Ltd., Novo Nordisk Inc., Ono Pharmaceutical Co., Ltd., Taisho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company Limited, Teijin Pharma Limited.
768-P: Efficacy and Safety of Low-Carb Diet of 50g/Day and 120g/Day in Obese Patients
Authors: KIKUCHI TAKAKO
Published: June 2019

Objective: Nutrition therapy is indispensable in the management of obesity. Low-carb diet is one of the recommended diets. On the other hand, there is little evidence on Low-carb diet in Japan. Besides, we don’t know the optimum amount of carbohydrate. So, we tried to ellucidate the efficacy and safeness of Low-carb diet, and to compare two amounts of Low-carb diet: 50g (LC50g) or 120g carb/day (LC120g).

Research Design and Methods: 42 Overweight or obese Japanese adults with one or more metabolic disorders (such as diabetes, hyperlipidemia, hypertension) were randomly assigned to a 3-month Low-Carb diet intervension (50g or 120g carb/day). All food was provided, and patients were assigned to report what they ate every day to the registered dietitian via mail, so that we could check compliance. Total calorie was calculated based on the ideal body weight and physical activity index. Every month, body weight, body composition (measured by multi-frequency BIA) were checked. Blood pressure, HbA1c, FPG, serum ketone body, kidney and liver function and lipid profile, serum C-peptide, urinary albumin, PWV/ABI were checked. We used T test for statistic analysis.

Results: No one dropped out. Median age and BMI were 43 and 28.5. Change in BW was -8.5kg in LC50g, -7.2kg in LC120g, there was no significant difference. AST, ALT, γGTP, LDH, Cre decreased after intervention in both groups. LDH, Cre significantly decreased in LC50g. Acetoacetic acid and EPA significantly increased in LC50g. Baseline analysis showed, BW at age 20, early rising, dinner time and exercise habits were related to susceptibility to losing weight. A questionnaires survey revealed patients felt more stressful in LC50g.

Conclusion: In this study, both amount of carb restriction was effective and safe, and there was no significant difference in losing weight, diabetes, lipid and hypertension control. LC120g was easy to carry out. Finally, this study is the one and only because it achieved high compliance by food offering and on time follow-up.

Disclosure

T. Kikuchi: None.
77-LB: Digital Behavioral Counseling in a Workforce Setting Reduces 8-Year Risk of Developing Type 2 Diabetes
Authors: BIRSE CHARLES E. , FRAGALA MAREN S. , SATISH ANITA , MCNAMARA KELSEY C. , CASTRO SWEET CYNTHIA M. , LAGIER ROBERT J.
Published: June 2019

Background: Digital behavioral counseling has previously been shown to reduce levels of risk factors for diabetes including fasting glucose and HbA1c. We asked whether the 8-year risk of developing diabetes could be reduced within the first year of a digital counseling program.

Methods: Individuals were included in the study if they (i) participated in an employer-sponsored wellness program with year-end biometric screening for 3 consecutive years (2016, 2017, and 2018), (ii) had prediabetes-range fasting glucose (100 to 125 mg/dL) or Hb1Ac (5.7% to 6.4%), (iii) a BMI ≥25 kg/m2 at the end of 2017, and (iv) completed at least 9 lessons in a digital behavioral counseling program initiated at the beginning of 2018. Paired t-Tests were used to assess changes in yearly trajectories of diabetes risk factors before and after intervention (Table).

Results: The baseline characteristics of the cohort at the 2017 year-end screen are provided (Table). On average, participants (n=460) were engaged in the counseling program for 9.1 months (SD: 1.2) and completed 25.1 lessons (SD: 12.3). After participation, levels of all biometric variables included in the 8-year risk model* shifted in a favorable direction; the 8-year risk of developing diabetes was reduced (Table).

Conclusions: Digital behavioral counseling was effective in reducing risk factors and the 8-year risk of diabetes during the first year of the program.

Disclosure

C.E. Birse: Employee; Self; Quest Diagnostics. Stock/Shareholder; Self; Quest Diagnostics. M.S. Fragala: Employee; Self; Quest Diagnostics. A. Satish: None. K.C. McNamara: Employee; Self; Omada Health, Inc. C.M. Castro Sweet: Employee; Self; Omada Health, Inc. R.J. Lagier: Employee; Self; Quest Diagnostics.
784-P: Effects of Low-Carb and Low-Fat Dietary Strategies on Lipid Profile in Subjects with Prediabetes—DiNA-P
Authors: MEYER NINA , DIEKMANN LAVINIA MURIELLE , KABISCH STEFAN , DAMBECK ULRIKE , PFEIFFER ANDREAS F.
Published: June 2019

Prediabetes as precursor of diabetes is characterized by a disorder in glucose metabolism, but is often associated with an impaired fat metabolism, too, defined by higher serum levels of cholesterol and/or triglycerides. Hyperlipidemia and a poor LDL/HDL ratio represent important risk factors for cardiovascular diseases. The risk is even higher in presence of NAFLD, a common comorbidity in subjects with (pre-)diabetes. Thus, amelioration of these metabolic disorders is important. Both hyperglycemia and hyperlipidemia can initially be treated by dietary approaches. Low-fat diets, but possibly even more low-carb diets seem to improve metabolic parameters.

Thus, we compare the effect of a low-carb or low-fat diet in subjects with prediabetes, focusing on predefined lipid parameters and liver fat, investigating possible mechanisms by which cardiometabolic risk factors can be reduced.

Our analysis is conducted within a preliminary sample of the ongoing DiNA-P (Diabetes Nutrition Algorithms in Prediabetes) study, covering 12 months of dietary intervention in 176 subjects of which 155 completed the study by now. Lipid metabolism is assessed by total cholesterol, LDL, HDL, LDL/HDL ratio and triglyceride serum levels, liver fat by magnetic resonance spectroscopy. Statistical analysis is based on within-group and between-group comparisons as well as non-parametric correlation analysis (Spearman). Level of significance is p<0,05.

Within the low-fat group, an improvement in all lipid parameters except for HDL cholesterol can be stated. Also, the LDL/HDL ratio as well as liver fat content were reduced in the end of the study. Within the low-carb group, the same favorable development was observed. Additionally, HDL-cholesterol showed a significant improvement, resulting in a significantly different development of HDL cholesterol in the low-carb group compared to low-fat. Our findings are confirmed by subgroup analysis, stratified by use of lipid lowering medication.

Disclosure

N. Meyer: None. L. Diekmann: None. S. Kabisch: Research Support; Self; California Walnut Commission, Institute for Grain Processing, Nuthetal, J. Rettenmaier Söhne, Südzucker / Beneo. Other Relationship; Self; Berlin-Chemie AG, Sanofi. U. Dambeck: None. A.F. Pfeiffer: Advisory Panel; Self; Abbott, Berlin-Chemie AG, Novo Nordisk A/S. Speaker's Bureau; Self; Lilly Diabetes, Novartis AG, Sanofi-Aventis Deutschland GmbH.
786-P: Serum Dehydroepiandrosterone Sulfate Concentration and Animal Protein Intakes Are Important Factors for Skeletal Muscle Mass in Japanese Patients with Type 2 Diabetes
Authors: MOYAMA SHOTA , KUWATA HITOSHI , HAMAMOTO YOSHIYUKI , YABE DAISUKE , SEINO YUTAKA
Published: June 2019

The aim of this study was to examine the association between serum reproductive hormone concentrations, dietary intakes and skeletal muscle mass in patients with type 2 diabetes. This cross-sectional study investigated 54 Japanese patients with type 2 diabetes (32 males) during the period between 2014 to 2018. All patients completed measurements of serum dehydroepiandrosterone sulfate concentration (DHEA-S), skeletal muscle index (SMI) and dietary intakes at same period. Those who had adrenal tumor, thyroid cancer, and thyroid dysfunction were excluded. In the analysis, as a first-step, we conducted single regression analysis between age, DHEA-S, SMI, total energy and each macronutrient intakes. SMI was positively correlated with total energy and protein intakes. Interestingly, while protein intakes derived from animal foods were positively correlated with SMI, those from plant foods showed negative correlation. On the other hand, DHEA-S was positively correlated with SMI. Then, multiple regression analysis (MRS) was performed to examine the contributors to SMI (Table). MRS revealed the association of SMI with DHEA-S and protein intakes. Our data suggest that DHEA-S and protein intakes are the factors contribute to SMI in Japanese patients with type 2 diabetes.

Disclosure

S. Moyama: None. H. Kuwata: Research Support; Self; Eli Lilly and Company. Y. Hamamoto: Speaker's Bureau; Self; Novo Nordisk A/S. D. Yabe: Advisory Panel; Self; Abbott. Research Support; Self; Astellas Pharma Inc. Speaker's Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Daiichi Sankyo Company, Limited, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk Inc., Ono Pharmaceutical Co., Ltd., Sanofi K.K., Taisho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company Limited. Y. Seino: Research Support; Self; Arkray, Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Merck & Co., Inc., Novo Nordisk Inc., Ono Pharmaceutical Co., Ltd., Taisho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company Limited, Terumo Medical Corporation.
788-P: Effects of Sucralose Ingestion vs. Sucralose Taste on Metabolic Responses to a Glucose Load in Subjects with Normal Weight and Obesity
Authors: M. YANINA PEPINO , NICHOL ALEXANDER D. , ROTHER KRISTINA , SALAME CLARA
Published: June 2019

Objective: Consumption of low-calorie sweeteners (LCS) is associated with abnormalities of glucose metabolism. Here we evaluate the effects of sucralose ingestion, versus sucralose taste (i.e., sham feeding), on metabolic responses to a labeled oral glucose tolerance test (OGTT) in subjects with normal weight and obesity.

Research Design and Methods: Ten normal-weight (BMI: 23±1 kg/m2) and 11 subjects with obesity (BMI: 38±6 kg/m2), all non-habitual users of LCS, underwent 3 dual-tracer OGTTs preceded by consuming 48 mg of sucralose, water, or sham feeding sucralose in randomized order. Indices of β-cell function and insulin sensitivity (SI) were estimated by using oral minimal models of glucose, insulin and C-peptide kinetics.

Results: Compared to water, sucralose ingestion (but not sham feeding) increased the glucose incremental area under the curve by 30±10% in both groups. In contrast, sucralose had different effects on plasma insulin concentrations in these groups (P<0.01). Sucralose ingestion decreased the magnitude of the glucose-induced increase in insulin concentrations 20-40 min post-glucose load in normal-weight subjects, but increased it 90-120 min post-glucose load in subjects with obesity. Sucralose sham-fed similarly decreased the magnitude of the glucose-induced increase in insulin concentrations within 60 min of the OGTT in both groups. In addition, sucralose ingestion (but not sham feeding) increased SI in normal-weight subjects by 52±20% but did not affect SI in subjects with obesity (P<0.02). Sucralose did not affect glucose kinetics or indices of the sensitivity of the β-cell response to glucose in either group.

Conclusions: Acute sucralose ingestion differentially affects glucose metabolism in subjects with normal weight versus obesity. In addition, our findings underscore a physiological role for sweetness in glucose homeostasis, which supports the notion that sweetness should be used in moderation.

Disclosure

M. Pepino: None. A.D. Nichol: None. K. Rother: None. C. Salame: None.

Funding

National Institutes of Health (P30DK020579, P60DK020579, P30DK056341); National Institute of Diabetes and Digestive and Kidney Diseases