NCT01736865已完成2 期
Vitamin D for Established Type 2 Diabetes (DDM2)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 2
- 主要终点
- Disposition Index
研究概览
简要总结
This research study in adults with established type 2 diabetes will test whether daily vitamin D supplementation affects how the body processes glucose (sugar).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established type 2 diabetes, defined by one of the following two criteria:
- •Age ≥ 25 years and ≤ 75 years
- •BMI: 23 to 40 kg/m2 inclusive
- •Provision of signed and dated written informed consent prior to any study procedures.
- •Major Exclusion Criteria
- •"Severe" diabetes defined by one of the following criteria:
- •- (a) Symptoms of hyperglycemia;
- •- (b) Screening HbA1c ≥ 7.5 [may indicate potential for rapid progression during the trial necessitating need to amplify diabetes-specific pharmacotherapy]
- •History of nephrolithiasis or hypercalcemia
排除标准
- 未提供
研究组 & 干预措施
placebo
Placebo Comparator
One placebo pill daily for 1 year
干预措施: Placebo (Drug)
cholecalciferol
Active Comparator
One cholecalciferol pill daily for 1 year
干预措施: Cholecalciferol (Drug)
结局指标
主要结局
Disposition Index
时间窗: 6 months
Disposition index by the insulin secretion sensitivity index-2 (ISSI-2). This is an calculated value which represents the ability of a person's pancreatic beta cells to lower blood glucose. A higher number means the pancreas is better able to secrete insulin and improve glucose levels.
次要结局
- Number of Participants With Change in Glycemia(12 months)
研究者
研究点 (2)
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