Overview

This trial is active, not recruiting.

Condition morbid obesity
Treatments gastric bypass, gastric banding, sleeve gastrectomy
Sponsor Washington University School of Medicine
Collaborator Ethicon Endo-Surgery
Start date September 2009
End date September 2016
Trial size 60 participants
Trial identifier NCT00981500, 09-0175

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
morbidly obese subjects undergoing gastric bypass surgery
gastric bypass Roux-en-Y gastric bypass
Roux-en-Y gastric bypass
morbidly obese subjects undergoing laparoscopic gastric banding surgery
gastric banding lap band
laparoscopic adjustable gastric banding
morbidly obese subjects undergoing sleeve gastrectomy
sleeve gastrectomy gastric sleeve
vertical sleeve gastrectomy

Primary Outcomes

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

Secondary Outcomes

Measure
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
time frame: 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.
time frame: at 20% weight loss post surgery
Identify host genes that co-vary with an altered metagenome in obese individuals that undergo bariatric surgery
time frame: at 20% weight loss post surgery.
Investigate how the metagenome is affected by bariatric surgery procedures leading to weight reduction
time frame: 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.
time frame: at 20% weight loss post surgery

Eligibility Criteria

Male or female participants from 20 years up to 70 years old.

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

Additional Information

Official title Effect of Bariatric Surgery-induced Weight Loss on Glucose Homeostasis
Principal investigator Samuel Klein, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.