Glucose Homeostasis Pre and Post Bariatric Surgery

Completed

• Conditions: Morbid Obesity
• Interventions: Procedure: gastric bypass; Procedure: gastric banding; Procedure: sleeve gastrectomy

• Registration Number: NCT00981500
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2009-09-18
• Study First Submitted QC: 2009-09-21
• Study First Posted: 2009-09-22
• Study Start: 2009-12
• Primary Completion: 2014-06
• Study Completion: 2018-06
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-09
• Last Update Posted: 2018-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• BMI ≥ 35 kg/m²
• on stable dose of medications for at least 4 weeks before the pre-surgery metabolic studies

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gastric Bypass	gastric bypass	morbidly obese subjects undergoing gastric bypass surgery
gastric banding	gastric banding	morbidly obese subjects undergoing laparoscopic gastric banding surgery
sleeve gastrectomy	sleeve gastrectomy	morbidly obese subjects undergoing sleeve gastrectomy

Primary Outcome Measures

Name	Time	Method
The effect of bariatric surgery-induced weight loss (Roux-en-Y gastric bypass, sleeve gastrectomy, and laparoscopic adjustable banding) on insulin action	at 20% weight loss post surgery

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States