Effect of 1,25-dihydroxyvitamin D3, Treatment on Insulin Secretion and Muscle Strength in Pre-diabetic Persons
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Glucose Levels
研究概览
简要总结
The purpose of this research is to study the effects of 1,25(OH)2 D3 (a prescription form of active Vitamin D) on muscle strength and insulin secretion by the pancreas and glucose utilization by skeletal muscle.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) of >24kg/m2
- •Fasting serum glucose <126 mg/dL
排除标准
- •BMI</=24 kg/m2
- •Fasting serum glucose >/=126 mg/dL
- •Patient is taking Calcium or Vitamin D supplements and is unwilling to stop for 8 weeks
- •Serum Calcium >10.2 mg/dL
- •Serum inorganic phosphorous >4.5mg/dL
- •Pregnancy or breastfeeding
- •Diagnosis of Diabetes Mellitus
- •Diagnosis of Rheumatoid Arthritis
- •Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
- •Renal in sufficiency/failure ( serum creatinine >1.5 mg/dL men, > 1.3 mg/dL women)
- •Chronic active liver disease (bilirubin >1.2 mg/dL, AST>144IU/L, or ALT >165 IU/L)
- •History of chronic hepatitis
- •Active coronary artery disease ( unstable angina, myocardial infarction, stroke and revascularization of coronary, peripheral or carotid artery within the last 3 months)
- •Oral warfarin group medications or history of blood clotting disorders
- •Platelet count <100,000 per uL within the last 7 days
- •Alcohol consumption greater than 2 glasses/day or other substance abuse
- •Untreated or uncontrolled thyroid disorders (outside a TSH range of 0.5 to 10mIU/L)
- •Debilitating chronic disease (at the discretion of the investigators)
- •The presence of infections, highly communicable diseases ( AIDS, active tuberculosis, venereal disease, hepatitis)
- •Any malignancy
研究组 & 干预措施
Men-Calcitriol
Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks.
干预措施: Calcitriol capsules (Drug)
Premenopausal Women-Calcitriol
Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks.
干预措施: Calcitriol capsules (Drug)
Men-Placebo
0.25mcg capsule daily for eight weeks
干预措施: Oral Placebo (Drug)
Premenopausal Women-Placebo
0.25mcg capsule daily for eight weeks
干预措施: Oral Placebo (Drug)
结局指标
主要结局
Glucose Levels
时间窗: Baseline and 8 weeks
Blood will be obtained to measure glucose after a glucose tolerance test. The glucose tolerance test involves an overnight fast and then participants will ingest a drink containing 75 grams of glucose with blood obtained over a 120 minute period.
C-Peptide Level
时间窗: Baseline and 8 weeks
Blood will be obtained to measure c-peptide level after a glucose tolerance test. The glucose tolerance test involves an overnight fast and then participants will ingest a drink containing 75 grams of glucose with blood obtained over a 120 minute period.
Insulin Level
时间窗: Baseline and 8 weeks
Blood will be obtained to measure insulin level after a glucose tolerance test. The glucose tolerance test involves an overnight fast and then participants will ingest a drink containing 75 grams of glucose with blood obtained over a 120 minute period.
次要结局
- PROMIS 10 Questionnaire(8 weeks)
研究者
Rajiv Kumar, M.D.
Principal Investigator
Mayo Clinic