A Randomized Controlled Trial of the Effect of Vitamin D Supplementation on Insulin Sensitivity and Secretion in Subjects With Type 2 Diabetes of Nordic and Sub-Indian Ethnicity .
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Insulin sensitivity measured with euglycemic, hyperinsulinemic clamp
研究概览
简要总结
The aim of this 6 months study is to evaluate the metabolic effects of 400.000-600.000 IU of vitamin D supplementation in subjects with type 2 diabetes and hypovitaminosis D. The main hypothesis is that subjects with low levels of 25-OH-vitamin D will benefit from supplementation with cholecalciferol in sufficient doses to optimize serum levels.
详细描述
Accumulating evidence suggests that hypovitaminosis D may be associated with the development of type 2 diabetes and disturbances in glucose and insulin metabolism. There is lack of data from randomized, controlled studies of sufficient duration and with the use of sufficient doses of vitamin D to assess the importance of vitamin D supplementation in glucose metabolism in type 2 diabetes.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Subjects not having type 2 diabetes.
- •SBP ≥ 160 or DBP ≥ 95 at Visit
- •Significant renal disease or chronic renal impairment, GFR< 30 ml/min.
- •Significant liver disease or ASAT or ALAT >3x UNL.
- •Malignancy during the last five years.
- •Hypercalcemia at Visit
- •A history of kidney stone disease
- •WOCBP unwilling or unable to use an acceptable method to avoid pregnancy.
- •Pregnant or breastfeeding women.
- •Chronic inflammatory disease in active phase
- •Long term (>2 weeks) use of corticosteroids last 3 months
- •Mental condition (psychiatric or organic cerebral disease) rendering the subject unable to understand the nature, scope and possible consequences of the study.
- •Drug or alcohol abuse.
- •BMI > 45 kg/m2 or bariatric surgery (<5 years).
- •Cardiovascular disease (myocardial infarction, unstable angina pectoris or stroke) during the last 6 months.
- •Any medical condition that in the judgment of the investigator would jeopardize the subject's safety or evaluation of the study drug for efficacy and safety.
研究组 & 干预措施
Cholecalciferol
干预措施: Cholecalciferol (Drug)
Placebo
干预措施: Orange juice (Other)
结局指标
主要结局
Insulin sensitivity measured with euglycemic, hyperinsulinemic clamp
时间窗: Before and after the 6 months intervention period
次要结局
- Insulin secretion measured with IVGTT(At 0 and 6 months)
- Physical activity/muscle strength(At 0 and 6 months)
- HbA1c and fasting glucose(At 0, 3 and 6 months)
- Arterial stiffness(At 0 and 6 months)
- Differences in inflammatory markers, endothelial function and bone specific laboratory markers.(At 0, 3 and 6 months)
- Safety of this regimen of vitamin D3 supplementation; subjects will be assessed for hypercalcemia and renal dysfunction.(Entire intervention period, samples taken at 0,1,3, and 6 months)
- Change from baseline in quality of life score between groups (SF-36).(At 0 and 6 months)
- Effect on serum lipid levels and other biochemical markers(At 0, 3 and 6 months)
- Metabolomics analyses.(At 0 and 6 months)