Effects of Pioglitazone on Body Composition,Insulin Sensitivity and Protein Metabolism in ESRD Non Diabetic Individuals
试验速览
- 阶段
- 4 期
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Body composition
研究概览
简要总结
Non diabetic patients on renal replacement therapy are prone to changes in body composition with an increase in visceral fat and muscle wasting all favoured by the insulin resistant state. Malnutrition is associated with a worst prognosis in these patients. Glitazones are the most powerful insulin sensitisers available in clinical practice which also have anti-inflammatory properties. Their use has been associated with significant and favourable changes in body fat distribution in type 2 diabetic subjects. Experimental studies suggest that glitazones may attenuate muscle wasting in renal failure.
The goal of this study was to examine in non diabetic ESRD patients the effects of pioglitazone on inulin sensitivity and protein metabolism as determined by the hyperinsulinemic euglycemic clamp and on changes in body composition as determined by anthropometric measurements, dual energy X-ray absorptiometry (DEXA) and CT-scan determined changes in abdominal visceral and sub-cutaneous fat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non diabetic individuals with ESRD, on hemodialysis or peritoneal dialysis for at least 3 months. Consent form signed -
排除标准
- •No infectious complication 3 months prior to entry in the study.
研究组 & 干预措施
Pioglitazone 45mg per day
Pioglitazone 45mg qd will be added to the current treatment
干预措施: Pioglitazone (Drug)
placebo
placebo qd will be added to current treatment
干预措施: Pioglitazone (Drug)
结局指标
主要结局
Body composition
时间窗: at the end of each treatment phase (which lasts 4 months)
Effect of pioglitazone on the body composition determined by DEXA, abdominal CT, anthropometric measurements.
Insulin sensitivity
时间窗: at the end of each treatment phase (which lasts 4 months)
Hepatic and whole body insulin sensitivity will be determined during the insulin glucose clamp.
Protein metabolism
时间窗: at the end of each treatment phase (which lasts 4 months)
Protein turnover will be determined by leucine infusion during the insulin glucose clamp
次要结局
未报告次要终点