Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Chang in Disposition Index, a Measure of Beta Cell Function
研究概览
简要总结
The purpose of the randomized trial is to quantify the effect of vitamin D and calcium supplementation on beta-cell function, insulin sensitivity, glucose tolerance and systemic inflammation and other cardiometabolic outcomes in ambulatory adults at high risk for type 2 diabetes.
详细描述
There is animal and human observational evidence to suggest that vitamin D and calcium are important in modifying t2DM risk but there are critical gaps in our knowledge about the clinical magnitude of the association with t2DM and potential mechanisms in humans. We are conducting a randomized trial to quantify the effect of vitamin D and calcium supplementation on beta-cell function, insulin sensitivity, glucose tolerance and systemic inflammation and other cardiometabolic outcomes in ambulatory adults at high risk for t2DM. We anticipate that the research proposed in this application is significant because it will provide the basis for defining feasible nutritional interventions that promotes prevention of t2DM. Based on the results of the proposed studies and future work in this area, vitamin D and calcium supplementation can assume an important role in the treatment of t2DM and in the prevention of the disease in the 41 million Americans who are at risk of developing t2DM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ethnicity: all ethnic groups
- •Gender: men and women
- •Lower age limit: 40 years inclusive
- •Upper age limit: NONE
- •Lower BMI limit: 25 inclusive
- •Upper BMI limit: 40 inclusive
- •Glucose Intolerance / Mild Diabetes defined as
- •Fasting glucose ≥100 mg/dl OR
- •2-hr glucose after OGTT ≥140 mg/dl OR
- •5.8 ≤ Hemoglobin A1c ≤ 7
排除标准
- •Diabetes requiring pharmacotherapy
- •Hyperparathyroidism
- •Hypercalcemia (Calcium > 10.5 mg/dl)
- •Kidney stone
- •Pregnancy
研究组 & 干预措施
1
Vitamin D3 2,000 IU daily plus Calcium Carbonate 400 mg twice daily
干预措施: Vitamin D3 2,000 IU orally once daily (Drug)
1
Vitamin D3 2,000 IU daily plus Calcium Carbonate 400 mg twice daily
干预措施: Calcium Carbonate 400 mg orally twice daily (Drug)
2
Vitamin D3 2,000 IU daily plus Calcium-Placebo twice daily
干预措施: Vitamin D3 2,000 IU orally once daily (Drug)
2
Vitamin D3 2,000 IU daily plus Calcium-Placebo twice daily
干预措施: Calcium-Placebo (Drug)
3
Vitamin D3-Placebo plus Calcium Carbonate 400 mg twice daily
干预措施: Calcium Carbonate 400 mg orally twice daily (Drug)
3
Vitamin D3-Placebo plus Calcium Carbonate 400 mg twice daily
干预措施: Vitamin D3-Placebo (Drug)
4
Vitamin D3-Placebo plus Calcium-Placebo
干预措施: Vitamin D3-Placebo (Drug)
4
Vitamin D3-Placebo plus Calcium-Placebo
干预措施: Calcium-Placebo (Drug)
结局指标
主要结局
Chang in Disposition Index, a Measure of Beta Cell Function
时间窗: baseline and 4 months
Range is 0 to infinity Lower is better.
次要结局
- Change in Hemoglobin A1c(Baseline to 4 months)
