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Completed

NCT Number: NCT00981500

Glucose Homeostasis Pre and Post Bariatric Surgery

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.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gastric bypass

Procedure

Roux-en-Y gastric bypass

Other names: Roux-en-Y gastric bypass

Gastric Banding

Procedure

laparoscopic adjustable gastric banding

Other names: lap band

Sleeve gastrectomy

Procedure

vertical sleeve gastrectomy

Other names: gastric sleeve

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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.

  4. Investigate how the metagenome is affected by bariatric surgery procedures leading to weight reduction

    Time frame: at 20% weight loss post surgery

  5. 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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Ethicon Endo-Surgery

Registry information

Official study title

Effect of Bariatric Surgery-induced Weight Loss on Glucose Homeostasis

Acronym: RB

Important dates

Study start
2009
Primary completion
2014
Study completion
2018
First posted
Sep 22, 2009
Registry last updated
Aug 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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