Baseline Characteristics of the Vitamin D and Type 2 Diabetes (D2d) Study: A Contemporary Prediabetes Cohort That Will Inform Diabetes Prevention Efforts

• Published in: Diabetes care Vol. 41; no. 8; pp. 1590 - 1599
• Main Authors: LeBlanc, Erin S, Pratley, Richard E, Dawson-Hughes, Bess, Staten, Myrlene A, Sheehan, Patricia R, Lewis, Michael R, Peters, Anne, Kim, Sun H, Chatterjee, Ranee, Aroda, Vanita R, Chadha, Chhavi, Neff, Lisa M, Brodsky, Irwin G, Rosen, Clifford, Desouza, Cyrus V, Foreyt, John P, Hsia, Daniel S, Johnson, Karen C, Raskin, Philip, Kashyap, Sangeeta R, O'Neil, Patrick, Phillips, Lawrence S, Rasouli, Neda, Liao, Emilia P, Robbins, David C, Pittas, Anastassios G
• Format: Journal Article
• Language: English
• Published: United States American Diabetes Association 01-08-2018
• Subjects: Adult; Adults; Aged; Aged, 80 and over; Blood Glucose - metabolism; Body mass; Cholecalciferol - therapeutic use; Clinical Care/Education/Nutrition/Psychosocial Research; Clinical trials; Cohort Studies; Criteria; Diabetes; Diabetes mellitus; Diabetes mellitus (non-insulin dependent); Diabetes Mellitus, Type 2 - blood; Diabetes Mellitus, Type 2 - epidemiology; Diabetes Mellitus, Type 2 - prevention & control; Dietary Supplements; Disease control; Disease prevention; Double-Blind Method; Female; Glucose; Glycated Hemoglobin - analysis; Health risks; Hemoglobin; Humans; Incidence; Male; Metabolic syndrome; Middle Aged; Prediabetic State - blood; Prediabetic State - diagnosis; Prediabetic State - drug therapy; Prediabetic State - epidemiology; Randomization; Research design; Risk; Vitamin D; Vitamin D - blood; United States > US
• ISSN: 0149-5992; 1935-5548
• DOI: 10.2337/dc18-0240

To describe baseline characteristics of the Vitamin D and Type 2 Diabetes (D2d) study, the first large U.S. diabetes prevention clinical trial to apply current American Diabetes Association (ADA) criteria for prediabetes.
This is a multicenter (
= 22 sites), randomized, double-blind, placebo-controlled, primary prevention clinical trial testing effects of oral daily 4,000 IU cholecalciferol (D
) compared with placebo on incident diabetes in U.S. adults at risk for diabetes. Eligible participants were at risk for diabetes, defined as not meeting criteria for diabetes but meeting at least two 2010 ADA glycemic criteria for prediabetes: fasting plasma glucose (FPG) 100-125 mg/dL, 2-h postload glucose (2hPG) after a 75-g oral glucose load 140-199 mg/dL, and/or a hemoglobin A
(HbA
) 5.7-6.4% (39-46 mmol/mol).
A total of 2,423 participants (45% of whom were women and 33% nonwhite) were randomized to cholecalciferol or placebo. Mean (SD) age was 59 (9.9) years and BMI 32 (4.5) kg/m
. Thirty-five percent met all three prediabetes criteria, 49% met the FPG/HbA
criteria only, 9.5% met the 2hPG/FPG criteria only, and 6.3% met the 2hPG/HbA
criteria only. Black participants had the highest mean HbA
and lowest FPG concentration compared with white, Asian, and other races (
< 0.01); 2hPG concentration did not differ among racial groups. When compared with previous prediabetes cohorts, the D2d cohort had lower mean 2hPG concentration but similar HbA
and FPG concentrations.
D2d will establish whether vitamin D supplementation lowers risk of diabetes and will inform about the natural history of prediabetes per contemporary ADA criteria.