Glucose Homeostasis Pre and Post Bariatric Surgery

Morbid Obesity Clinical Trial

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Official title:

Effect of Bariatric Surgery-induced Weight Loss on Glucose Homeostasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00981500
• Other study ID #: 09-0175
• Status: Completed
• Start date: December 2009
• Est. completion date: June 2018

Study information

• Verified date: August 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2018
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Procedure:
• gastric bypass
Roux-en-Y gastric bypass
• gastric banding
laparoscopic adjustable gastric banding
• sleeve gastrectomy
vertical sleeve gastrectomy

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Ethicon Endo-Surgery

Country where clinical trial is conducted

United States, 

Outcome

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