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Glucose Homeostasis Pre and Post Bariatric Surgery (RB)

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The Washington University

Status

Completed

Conditions

Morbid Obesity

Treatments

Procedure: sleeve gastrectomy
Procedure: gastric bypass
Procedure: gastric banding

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT00981500
09-0175

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

60 participants in 3 patient groups

Gastric Bypass
Description:
morbidly obese subjects undergoing gastric bypass surgery
Treatment:
Procedure: gastric bypass
gastric banding
Description:
morbidly obese subjects undergoing laparoscopic gastric banding surgery
Treatment:
Procedure: gastric banding
sleeve gastrectomy
Description:
morbidly obese subjects undergoing sleeve gastrectomy
Treatment:
Procedure: sleeve gastrectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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