NCT01497132已完成4 期
Effects of Vitamin D on Beta Cell Function and Insulin Sensitivity in Pre-diabetes and Diabetes Mellitus Type 2 - EVIDENS
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Beta cell function
研究概览
简要总结
The purpose of this study is to evaluate if treatment with vitamin D increase beta cell function and insulin sensitivity in subjects with pre-diabetes or newly diagnosed diabetes mellitus type 2.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meeting criteria for IFG, IGT, IFG+IGT or diabetes mellitus at OGTT.
- •BMI ≤ 32 kg/m
- •HbA1c ≤ 7.0 % (MonoS) or ≤ 63 mmol/mol (IFCC).
- •Fasting plasma glucose < 9 mmol/l
- •S-25-OH-vitamin D3 < 75 nmol/l.
排除标准
- •Treatment with any vitamin D preparation.
- •Regular sun-bathing in solarium.
- •Hypercalcemia at screening, defined as free s-calcium > 1.35 mmol/l.
- •Hyperphosphatemia at screening, defined as s-phosphate > 1.5 mmol/l.
- •Sarcoidosis or other granulomatous disease.
- •Treatment with phenytoin, barbiturates, rifampicin, isoniazid, cardiac glycosides, orlistat or colestyramin.
- •Impaired hepatic function.
- •Impaired renal function
- •Cardiac disease defined as:
- •Unstable angina pectoris
- •Myocardial infarction within the last 6 months
- •Congestive heart failure NYHA class III and IV
- •Cerebral stroke within the last 6 months.
- •Anti-diabetic medication of any kind.
- •Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.
研究组 & 干预措施
Vitamin D3
Experimental
干预措施: Vitamin D3 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Beta cell function
时间窗: 8 weeks
Assessed by hyperglycemic clamp investigation
次要结局
- Insulin sensitivity(8 weeks)
- Glucose tolerance(8 weeks)
- Hypercalcemia(8 weeks)
研究者
Henrik Wagner
Principal Investigator
Karolinska Institutet
研究点 (1)
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