Vitamin D, Insulin Resistance, and Cardiovascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Hypertension (24h Blood Pressure, Central Blood Pressure, and Office BP)
研究概览
简要总结
In recent years, vitamin D has been shown not only to be important for bone and calcium metabolism but also for homeostasis of critical tissues involved in vascular disease in patients with diabetes. Epidemiological studies indicated the high prevalence of vitamin D deficiency among Type 2 DM patients and suggest an increased risk of cardiovascular disease and hypertension with low vitamin D levels. The objective of this proposal is to evaluate the effects of vitamin D replacement on blood pressure control and vascular disease in vitamin D deficient hypertensive patients with diabetes
详细描述
This is a double blinded, placebo controlled trial. Patients who meet the inclusion criteria will be randomized to placebo or 25(OH)D3, 4,000 IU/d orally for 16 weeks. Enrolled patients will be tested for 24h-blood pressure, brachial arterial blood flow, vascular inflammatory markers and macrophage inflammatory response to modified-lipoproteins at baseline, middle and at the end of the study.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •25 (OH) vitamin D levels < 25 ng/ml
- •Age 25 to 80 years
- •Not on insulin for diabetes treatment
- •HbA1c 5.5% -9.5%
- •Mild/moderately increased blood pressure (systolic 120-160, diastolic 80-100) off BP medications
排除标准
- •Pregnancy
- •Patients with systolic >160 or diastolic >100 mmHg
- •High urine calcium or history of recurrent kidney stones
- •Cardiovascular disease
- •Stage 3 or worse chronic kidney disease
研究组 & 干预措施
Placebo
Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily.
干预措施: Placebo (Drug)
Vitamin D
Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.
干预措施: Vitamin D3 (Drug)
结局指标
主要结局
Hypertension (24h Blood Pressure, Central Blood Pressure, and Office BP)
时间窗: 0, 2, and 4 months
24-hour blood pressure collected by ambulatory automated arm cuff, central mean arterial blood pressure (MAP) collected by non-invasive arterial tonometry and pulse wave analysis/pulse wave velocity, office blood pressure collected by manual aneroid sphygmomanometry.
次要结局
- Brachial Artery Reactivity Testing(0, 2, and 4 months)
- Serum Calcium(0, 2, and 4 Month)
- Macrophage Cholesterol Metabolism(0 and 4 months)
- Fasting Glucose(0, 2, and 4 Month)
- Urine Calcium to Creatinine Ratio.(0, 2 and 4 Months)
- Vitamin D(0, 2, and 4 Month)
- hsCRP(0, 2, and 4 Month)
- HbA1C(0, 2, and 4 month)