D Vitamin Intervention in VA

US Department of Veterans Affairs205 enrolled

Overview

This study will supplement African American male (AAM) veterans at risk for diabetes and newly diagnosed T2DM with vitamin D (low or higher dose) and evaluate whether vitamin D helps to improve early markers of diabetes. The study will be done at Veteran Administration Medical Center in Chicago.

The goal of this randomized clinical trial (RCT) is to determine vitamin D efficacy and safety for improving early markers of T2DM in African American male (AAM) veterans at risk for T2DM (n=205, duration 12 months). The primary outcome will be change in oral glucose insulin sensitivity (OGIS). The secondary outcomes will include various parameters of glucose metabolism and other biomarkers. Analysis based on primary and secondary goal as well as predetermined levels of A1C, OGTT and 25OHD at the end of the study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

205

Conditions

Impaired Fasting Glucose Impaired Glucose Tolerance Vitamin D Insufficiency

Interventions

PlaceboDRUG

Supplement of vitamin D 400 units provided to all subjects, in addition Arm 1 will get placebo and Arm 2 will get D2 50K

50K vitamin D2DRUG

Supplement of vitamin D 400 units provided to all subjects, in addition Arm 1 will get placebo and Arm 2 will get D2 50K

Eligibility

Sex: MALEMin age: 35 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: Veterans at Jesse Brown VA Medical Center (JBVAMC) only * Male * African American race * Age 35-85 years * BMI 28-39.9 kg/m2 * Stable weight (+/- 10%) for at least 3 months prior to study entry * FPG 95 - 125 mg/dl * A1C 5.7 - 6.4% * Circulating 25OHD 5.0 - 29.9 ng/ml * Subjects who take ergocalciferol are allowed in the study after a washout period 1 3 month. * Subjects who take vitamin D supplements other than ergocalciferol are allowed in the study as long as total dose is no more than 600 IU/day (including MVI and calcium plus D supplements). * Non-diabetic subjects who are diagnosed with T2DM during screening (A1C 6.5-7%) or after randomization are allowed to continue if they follow lifestyle intervention and do not need to take anti-diabetic medications. Exclusion Criteria: * Subjects with T2DM * Weight gain or loss of more than 10% within 3 months prior to the study entry * History of kidney stones, hyperparathyroidism, sarcoidosis or hypercalcemia * A1C \>7%. * Very low 25OHD levels (\<5 ng/ml) and/or the presence of a physical consequence of very low vitamin D levels (hypocalcemia, hypophosphatemia, proximal muscle weakness) * Chronic kidney disease (CKD) stage 4 and 5 * Problems that in the judgment of PI may be associated with the risk to the subject or non-compliance * Subjects who take vitamin D supplements and not willing to go through washout period for ergocalciferol or to take no more than 600 IU/day of total vitamin D supplements * History, clinical manifestations or medications of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, psychiatric/ psychological disorders, or social circumstances which in the opinion of the investigator would be expected to interfere with the study or increase risk to the subject * Non-diabetic subjects who are diagnosed with T2DM after randomization and need to take anti-diabetic medications are brought for the final visit

Locations (1)

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Oral Glucose Insulin Sensitivity (OGIS)

Oral glucose insulin sensitivity = index of insulin sensitivity, higher index means higher insulin sensitivity. Low insulin sensitivity means high insulin resistance and high risk of type 2 diabetes mellitus. It is calculated by a special formula using insulin and glucose measured in Oral Glucose Tolerance test. The primary outcome was the change in oral glucose insulin sensitivity (OGIS, from oral glucose tolerance test) after 12 months of treatment calculated as OGIS at 12-months minus OGIS baseline.

Time frame: 12 months

Secondary Outcomes

Change in HbA1c From Baseline at 12 Months

Time frame: Baseline and 12 Months

Insulin Sensitivity by Matsuda Composite

Insulin Sensitivity by Matsuda Composite - index of insulin sensitivity, higher index means higher insulin sensitivity. Low insulin sensitivity means high insulin resistance and high risk of type 2 diabetes mellitus. It is calculated by a special formula using insulin and glucose measured in Oral Glucose Tolerance test. The formula is different from a formula for OGIS. Matsuda composite calculated based on formula 10\^4/Square Root of \[(fasting glucose x fasting insulin) x (mean glucose x mean insulin)\] (Matsuda M, DeFronzo RA. Insulin sensitivity indices obtained from oral glucose tolerance testing: comparison with the euglycemic glucose clamp. Diabetes Care. 1999;22:1462-1470) Unit of measure is 10000/√\[(µU/mL)/(mg/dL)\]x\[(µU/mL)/(mg/dL)\].

Time frame: 12 Months

Insulinogenic Index-30

Index of insulin secretion, higher index means higher insulin secretion. It is calculated by a special formula using insulin and glucose measured at 0 min and at 30 min (hence 30 in the name) in Oral Glucose Tolerance test. Insulin secretion was assessed based on formula Insulinogenic index-30 \[(insulin at 30 min - fasting insulin)/(glucose at 30 min - fasting glucose)\] (Kosaka K, Hagura R, Kuzuya T. Insulin responses in equivocal and definite diabetes, with special reference to subjects who had mild glucose intolerance but later developed definite diabetes. Diabetes. 1977;26:944-952)

Data from ClinicalTrials.gov

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