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Baseline Characteristics of the Vitamin D and Type 2 Diabetes (D2d) Study: A Contemporary Prediabetes Cohort That Will Inform Diabetes Prevention Efforts.
Diabetes Care. 2018 08; 41(8):1590-1599.DC

Abstract

OBJECTIVE

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.

RESEARCH DESIGN AND METHODS

This is a multicenter (n = 22 sites), randomized, double-blind, placebo-controlled, primary prevention clinical trial testing effects of oral daily 4,000 IU cholecalciferol (D3) 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 A1c (HbA1c) 5.7-6.4% (39-46 mmol/mol).

RESULTS

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/m2. Thirty-five percent met all three prediabetes criteria, 49% met the FPG/HbA1c criteria only, 9.5% met the 2hPG/FPG criteria only, and 6.3% met the 2hPG/HbA1c criteria only. Black participants had the highest mean HbA1c and lowest FPG concentration compared with white, Asian, and other races (P < 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 HbA1c and FPG concentrations.

CONCLUSIONS

D2d will establish whether vitamin D supplementation lowers risk of diabetes and will inform about the natural history of prediabetes per contemporary ADA criteria.

Authors

No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, N.I.H., Intramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

29941495

Citation

LeBlanc, Erin S., et al. "Baseline Characteristics of the Vitamin D and Type 2 Diabetes (D2d) Study: a Contemporary Prediabetes Cohort That Will Inform Diabetes Prevention Efforts." Diabetes Care, vol. 41, no. 8, 2018, pp. 1590-1599.
LeBlanc ES, Pratley RE, Dawson-Hughes B, et al. Baseline Characteristics of the Vitamin D and Type 2 Diabetes (D2d) Study: A Contemporary Prediabetes Cohort That Will Inform Diabetes Prevention Efforts. Diabetes Care. 2018;41(8):1590-1599.
LeBlanc, E. S., Pratley, R. E., Dawson-Hughes, B., Staten, M. A., Sheehan, P. R., Lewis, M. R., Peters, A., Kim, S. H., Chatterjee, R., Aroda, V. R., Chadha, C., Neff, L. M., Brodsky, I. G., Rosen, C., Desouza, C. V., Foreyt, J. P., Hsia, D. S., Johnson, K. C., Raskin, P., ... Pittas, A. G. (2018). Baseline Characteristics of the Vitamin D and Type 2 Diabetes (D2d) Study: A Contemporary Prediabetes Cohort That Will Inform Diabetes Prevention Efforts. Diabetes Care, 41(8), 1590-1599. https://doi.org/10.2337/dc18-0240
LeBlanc ES, et al. Baseline Characteristics of the Vitamin D and Type 2 Diabetes (D2d) Study: a Contemporary Prediabetes Cohort That Will Inform Diabetes Prevention Efforts. Diabetes Care. 2018;41(8):1590-1599. PubMed PMID: 29941495.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Baseline Characteristics of the Vitamin D and Type 2 Diabetes (D2d) Study: A Contemporary Prediabetes Cohort That Will Inform Diabetes Prevention Efforts. AU - LeBlanc,Erin S, AU - Pratley,Richard E, AU - Dawson-Hughes,Bess, AU - Staten,Myrlene A, AU - Sheehan,Patricia R, AU - Lewis,Michael R, AU - Peters,Anne, AU - Kim,Sun H, AU - Chatterjee,Ranee, AU - Aroda,Vanita R, AU - Chadha,Chhavi, AU - Neff,Lisa M, AU - Brodsky,Irwin G, AU - Rosen,Clifford, AU - Desouza,Cyrus V, AU - Foreyt,John P, AU - Hsia,Daniel S, AU - Johnson,Karen C, AU - Raskin,Philip, AU - Kashyap,Sangeeta R, AU - O'Neil,Patrick, AU - Phillips,Lawrence S, AU - Rasouli,Neda, AU - Liao,Emilia P, AU - Robbins,David C, AU - Pittas,Anastassios G, AU - ,, Y1 - 2018/06/25/ PY - 2018/01/31/received PY - 2018/03/12/accepted PY - 2018/6/27/pubmed PY - 2018/9/21/medline PY - 2018/6/27/entrez SP - 1590 EP - 1599 JF - Diabetes care JO - Diabetes Care VL - 41 IS - 8 N2 - OBJECTIVE: 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. RESEARCH DESIGN AND METHODS: This is a multicenter (n = 22 sites), randomized, double-blind, placebo-controlled, primary prevention clinical trial testing effects of oral daily 4,000 IU cholecalciferol (D3) 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 A1c (HbA1c) 5.7-6.4% (39-46 mmol/mol). RESULTS: 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/m2. Thirty-five percent met all three prediabetes criteria, 49% met the FPG/HbA1c criteria only, 9.5% met the 2hPG/FPG criteria only, and 6.3% met the 2hPG/HbA1c criteria only. Black participants had the highest mean HbA1c and lowest FPG concentration compared with white, Asian, and other races (P < 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 HbA1c and FPG concentrations. CONCLUSIONS: D2d will establish whether vitamin D supplementation lowers risk of diabetes and will inform about the natural history of prediabetes per contemporary ADA criteria. SN - 1935-5548 UR - https://www.unboundmedicine.com/medline/citation/29941495/Baseline_Characteristics_of_the_Vitamin_D_and_Type_2_Diabetes__D2d__Study:_A_Contemporary_Prediabetes_Cohort_That_Will_Inform_Diabetes_Prevention_Efforts_ L2 - http://care.diabetesjournals.org/cgi/pmidlookup?view=long&amp;pmid=29941495 DB - PRIME DP - Unbound Medicine ER -