Vitamin D Deficiency and Treatment in Male Veterans at Risk for Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 205
- 试验地点
- 1
- 主要终点
- Oral Glucose Insulin Sensitivity (OGIS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Veterans at Jesse Brown VA Medical Center (JBVAMC) only
- •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.
排除标准
- •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
研究组 & 干预措施
Arm 1
Placebo: One capsule weekly
干预措施: Placebo (Drug)
Arm 2
50K vitamin D2: One capsule weekly
干预措施: 50K vitamin D2 (Drug)
结局指标
主要结局
Oral Glucose Insulin Sensitivity (OGIS)
时间窗: 12 months
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.
次要结局
- C-Peptidogenic Index-30(12 Month)
- Incident Diabetes(12 Months)
- Change in HbA1c From Baseline at 12 Months(Baseline and 12 Months)
- Insulin Sensitivity by Matsuda Composite(12 Months)
- Insulinogenic Index-30(12 Month)