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Clinical Trials/NCT00981500
NCT00981500
Completed
Not Applicable

Effect of Bariatric Surgery-induced Weight Loss on Glucose Homeostasis

Washington University School of Medicine1 site in 1 country60 target enrollmentDecember 2009
ConditionsMorbid Obesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Morbid Obesity
Sponsor
Washington University School of Medicine
Enrollment
60
Locations
1
Primary Endpoint
The effect of bariatric surgery-induced weight loss (Roux-en-Y gastric bypass, sleeve gastrectomy, and laparoscopic adjustable banding) on insulin action
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2009
End Date
June 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • 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)

Study Sites (1)

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