Weight Loss Study-Mechanism Underlying the Improvement of Insulin Resistance in Response to Weight Loss
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- The Primary Outcome Will be the Leptin Levels at Baseline and 8 Weeks
研究概览
简要总结
The main purpose of this study is to assess factors mediating the changes in insulin sensitivity and glucose tolerance before and after 10 lbs ± or 2% weight loss reduction as well as 2, 3, 6, 12, and 24 months after initiation of a low calorie diet.
The investigators will also study the following:
- The impact of diet induced weight loss on hormones/adipokine levels
- The impact of diet induced weight loss on leptin tolerance
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for interventional group:
- •Adult men and women, age 18-50
- •English speaking
- •Body mass index (pre weight loss) ≥30 kg/m2 but <40 kg/m2
- •Willing to enroll in a low calorie full meal replacement weight loss program
- •Willing and able to take part in a multi year study involving visits
- •Inclusion Criteria for control group:
- •Adult men and women, age 18-50
- •English speaking
- •Body mass index (pre weight loss) ≥30 kg/m2 but <40 kg/m2
- •Willing and able to take part in a multi year study involving visits
排除标准
- 未提供
研究组 & 干预措施
Control Group
Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy
Weight loss group
Full Meal replacement Protocol
干预措施: Weight loss group (Full meal replacement products) (Dietary Supplement)
结局指标
主要结局
The Primary Outcome Will be the Leptin Levels at Baseline and 8 Weeks
时间窗: 8 weeks
The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment
The Primary Outcome Will be Insulin Levels at Baseline and 8 Weeks
时间窗: 8 weeks
The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment
The Primary Outcome Will be HOMA-IR at Baseline and 8 Weeks
时间窗: 8 weeks
The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment
次要结局
未报告次要终点
研究者
Christos Mantzoros
Professor of Medicine
Beth Israel Deaconess Medical Center