Integrating the Genetic and Metabolic Faces of Obesity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Adipose Cell Size Distribution
研究概览
简要总结
The goal of this study is to determine why some obese individuals develop insulin resistance and others do not. We hypothesize that an impairment in differentiation of fat cells (adipocytes) is responsible for the development of insulin resistance in select obese individuals. This study will evaluate obese individuals at baseline with respect to characteristics of adipocytes, including gene expression, and will then entail randomizing subjects to either weight loss or treatment with an insulin sensitizing drug (pioglitazone). Changes in insulin resistance will be associated with changes in adipocyte morphology and gene expression.
详细描述
Healthy overweight/obese individuals will be screened for insulin resistance. Both insulin resistant individuals and insulin sensitive individuals (to serve as controls) will be eligible to enroll. Fat cel biopsy and CT scan of the abdomen is required at baseline and after an intervention with either weight loss or pioglitazone (drug to improve insulin resistance). Subjects will repeat insulin resistance test after the intervention as well. Subjects will learn much about their metabolism in this study, and will have an opportunity to improve their insulin resistance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •nondiabetic defined as fasting plasma glucose < 126 mg/dL
- •body mass index 27 to 35 kg/m2
- •no major organ diseases
- •able to come to Stanford for regular clinical research center visits
- •English speaking or has own translator
排除标准
- •pregnancy/lactation
- •history of eating disorder or major psychiatric illness
- •allergy to thiazolidinedione
- •elevation of liver enzymes (> 2.5 times upper normal limit)
研究组 & 干预措施
pioglitazone
IR and IS subjects will be randomized to pioglitazone 45 mg daily for 16 wks for comparison with dietary weight loss intervention
干预措施: thiazolidinedione (Drug)
Dietary Weight Loss
IR and IS subjects will be randomized to dietary weight loss for 16 wks for comparison to pioglitazone intervention
干预措施: weight loss (Behavioral)
结局指标
主要结局
Adipose Cell Size Distribution
时间窗: 2005-2012
次要结局
- Adipose Tissue Gene Expression(2005-2013)
研究者
Tracey McLaughlin
Associate Professor of Medicine
Stanford University