Effect of Bariatric Surgery-induced Weight Loss on Glucose Homeostasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The effect of bariatric surgery-induced weight loss (Roux-en-Y gastric bypass, sleeve gastrectomy, and laparoscopic adjustable banding) on insulin action
研究概览
简要总结
The investigators wish to study the effects of three forms of bariatric surgery: Roux-en-Y gastric bypass, Sleeve Gastrectomy, and Gastric Banding. The surgery is not part of the clinical trial. If your insurance does not cover the procedure, then you are responsible for payment of the surgical process. We are doing pre and post surgery testing to provide a better understanding of the effect of bariatric surgery-induced weight loss on metabolic function.
详细描述
Bariatric surgery is the most effective weight loss therapy for obesity. Moreover, the early improvement in insulin sensitivity and the resolution of type 2 diabetes after bariatric surgery has led to the hypothesis that bariatric surgery has specific beneficial effects on glucose homeostasis beyond weight loss alone. However, this hypothesis has never been adequately evaluated in human subjects. Therefore, the primary goal of this proposal is to provide a better understanding of the effect of bariatric surgery-induced weight loss on insulin action and pancreatic beta cell function.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI ≥ 35 kg/m²
- •on stable dose of medications for at least 4 weeks before the pre-surgery metabolic studies
排除标准
- •smokes > 7 cigarettes per day
- •previous malabsorptive or restrictive intestinal surgery
- •pregnant or breastfeeding
- •recent history of neoplasia (< 5 years ago)
- •have malabsorptive syndromes and inflammatory intestinal disease
- •diabetes mellitus
- •show signs of oral disease or xerostomia (i.e., dry mouth)
- •history of chronic rhinitis
- •on medication that might affect metabolism
- •severe organ dysfunction
结局指标
主要结局
The effect of bariatric surgery-induced weight loss (Roux-en-Y gastric bypass, sleeve gastrectomy, and laparoscopic adjustable banding) on insulin action
时间窗: at 20% weight loss post surgery
次要结局
- Investigate how the metagenome is affected by bariatric surgery procedures leading to weight reduction(at 20% weight loss post surgery)
- Determine the effect of bariatric surgery induced weight loss (Roux-en-Y gastric bypass, sleeve gastrectomy, and laparoscopic adjustable gastric banding) on gut microbiota.(at 20% weight loss post surgery)
- The effect of bariatric surgery-induced weight loss (Roux-en-Y gastric bypass, sleeve gastrectomy, and laparoscopic adjustable gastric banding) on postprandial plasma fibroblast growth factor (FGF)21 and FGF19 responses.(at 20% weight loss post surgery)
- Identify host genes that co-vary with an altered metagenome in obese individuals that undergo bariatric surgery(at 20% weight loss post surgery.)
- The effect of bariatric surgery-induced weight loss Roux-en-Y gastric bypass, sleeve gastrectomy, and laparoscopic adjustable gastric banding) on pancreatic beta cell response(at 20% weight loss post surgery)