The Effects of Chromium Supplementation on Glucose and Lipid Metabolism in Patients With HIV Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- insulin resistance calculated using fasting glucose and fasting insulin levels in blood
研究概览
简要总结
In HIV patients, fasting insulin levels decrease with chromium supplementation. This study is to determine if chromium nicotinate supplementation at 400ug/day for 16 weeks will improve insulin resistance in HIV patients with metabolic abnormalities.
详细描述
This study is a randomized, double-blind, placebo-controlled, crossover study where patients will be supplemented for 16 weeks with either chromium nicotinate 400 ug/day or placebo and then crossover to the opposite treatment for another 16 weeks. Each soft gel capsule of chromium contains 200ug of chromium and patients will take 1 capsule twice a day or its placebo. Placebo contains di-calcium phosphate in a soft gel capsule and its appearance is similar to the chromium capsules.
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
- 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
- •HIV documented patients will be considered for the study if they have at least one abnormality with respect to fasting blood glucose, TG, total or HDL cholesterol. Normal fasting glucose is defined as < 6.1 mmol/L. Hypertriglyceridemia is defined as concentrations above 2.0 mmol/L on the basis of reports of increased risk of cardiac disease. Hypercholesterolemia is defined as concentrations above 5.5 mmol/L and a low HDL-cholesterol concentration as less than 0.9 mmol/L.
- •Patients will need to be on a stable drug regimen for at least 8 weeks and not taking any chromium supplement or chromium-containing multivitamins 4 weeks prior to and during the study period. Patients can stay on their hypoglycemic or lipid-lowering medications and the required dosage will be monitored.
排除标准
- •Patients will be excluded if there is concomitant acute infection or malignancy.
研究组 & 干预措施
Chromium
400 μg (200 μg pills, twice per day) of Cr-nicotinate
干预措施: chromium nicotinate (Drug)
Placebo
Identical looking placebo (di-calcium phosphate)
干预措施: Placebo (Drug)
结局指标
主要结局
insulin resistance calculated using fasting glucose and fasting insulin levels in blood
时间窗: BL & 16 weeks
HOMA-IR
次要结局
- hemoglobin A1c (HbA1c)(BL & 16 weeks)
- blood lipid profile (triglycerides [TG], cholesterol or high-density lipoprotein [HDL])(BL & 16 weeks)
- body composition by dual energy x-ray absorptiometry (DEXA) scan, bioelectric impedance analysis and skin fold measurement(BL & 16 weeks)
- oxidative stress(BL & 16 weeks)
- plasma chromium(BL & 16 weeks)
研究者
Johane Allard
Gastroenterologist, Prof. of Medicine
University Health Network, Toronto