RYGB Improves Metabolism by Interrupting the Gastric Adipose Tissue Axis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- change in glucose disposal rate
研究概览
简要总结
The purpose of this study is to determine if interruption in gastric-adipose tissue axis signaling contributes to early improvements in oxidative stress, insulin sensitivity, and inflammation, and to determine if interruption of the stomach in RYGB results in reduction of plasma acylated ghrelin (AG) and in an altered acylated ghrelin:unacylated ghrelin (AG:UAG) ratio which may contribute to decreased oxidative stress and improved insulin sensitivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years
- •BMI ≥ 35 kg/m^2
- •Scheduled for bariatric surgery
- •Considering bariatric surgery
- •Waiting for insurance approval for bariatric surgery
- •Currently not considering bariatric surgery, but otherwise eligible
- •Enrollment in medical weight loss program
排除标准
- •Smoking >7 cigarettes per day
- •Precious malabsorptive or restrictive intestinal surgery
- •Pregnant or breastfeeding
- •Recent history of neoplasia (5<years ago)
- •Malabsorptive syndromes
- •Inflammatory intestinal disease
- •Established organ disfunction
- •Allergy to acetaminophen
研究组 & 干预措施
RYGB
Roux-en-Y gastric bypass surgery (RYGB) subjects to undergo hyperinsulinemic-euglycemic clamp with human ghrelin infusion pre-operatively and post-operatively.
干预措施: human ghrelin (Drug)
RYGB
Roux-en-Y gastric bypass surgery (RYGB) subjects to undergo hyperinsulinemic-euglycemic clamp with human ghrelin infusion pre-operatively and post-operatively.
干预措施: Hyperinsulinemic/Euglycemic Clamp (Procedure)
VSG
Vertical sleeve gastrectomy (VSG) subjects to undergo hyperinsulinemic-euglycemic clamp pre-operatively and post-operatively.
干预措施: Hyperinsulinemic/Euglycemic Clamp (Procedure)
Low Calorie Diet
Subjects will receive very low calorie diet prescribed for RYGB patients and undergo hyperinsulinemic-euglycemic before and after diet.
干预措施: very low calorie diet (Other)
Low Calorie Diet
Subjects will receive very low calorie diet prescribed for RYGB patients and undergo hyperinsulinemic-euglycemic before and after diet.
干预措施: Hyperinsulinemic/Euglycemic Clamp (Procedure)
结局指标
主要结局
change in glucose disposal rate
时间窗: baseline and 1 week
Glucose disposal rate is a sensitive laboratory procedure for determining how your body uses sugar (called insulin sensitivity).
次要结局
未报告次要终点
研究者
Naji Abumrad
Professor of Surgery, Chairman Department of Surgery
Vanderbilt University