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临床试验/NCT00857298
NCT00857298已完成不适用

Effect of Diet-induced Weight Loss on HIV-associated Metabolic Syndrome

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2009年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Effect of weight loss on body composition

研究概览

简要总结

Obese HIV-positive women with Metabolic Syndrome (HIV-MS) and obese HIV-negative women with Metabolic Syndrome will be studied before and after achieving moderate (6%-8%) diet-induced weight loss. The investigators hypothesize that health markers will improve in both groups but that the improvement will be blunted in the women with HIV-MS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Sedentary
  • •Have either dyslipidemia (HDL < 50 or triglycerides > 150), waist circumference > 88cm, and impaired glucose tolerance or homeostasis model assessment value of > 3
  • •Subjects with HIV-MS must have been receiving HAART for > 6 months

排除标准

  • •Medication changes in the last 3 months
  • •Diabetes mellitus
  • •Medical problems that in the opinion of the principal investigator may interfere with patient safety
  • •Substance abuse

研究组 & 干预措施

HIV-MS

Active Comparator

HIV-positive obese women with metabolic syndrome will be studied before and after losing 6-8% of body weight

干预措施: Dietary Intervention (Behavioral)

MS only

Active Comparator

HIV-negative obese women with metabolic syndrome will be studied before and after losing 6-8% of body weight

干预措施: Dietary Intervention (Behavioral)

结局指标

主要结局

Effect of weight loss on body composition

时间窗: three months

Effect of weight loss on insulin action

时间窗: three months

次要结局

  • Effect of weight loss on body fat mass(three months)
  • Effect of weight loss on adipose tissue distribution(three months)
  • Effect of weight loss intrahepatic triglyceride content(three months)
  • Effect of weight loss on insulin action adipose tissue(three months)
  • Effect of weight loss on insulin action in liver(three months)
  • Effect of weight loss on insulin action in skeletal muscle(three months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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