Glucose Homeostasis Pre and Post Bariatric Surgery

NCT ID: NCT00981500

Last Updated: 2018-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2018-06-30

Brief Summary

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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

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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.

Conditions

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Morbid Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Gastric Bypass

morbidly obese subjects undergoing gastric bypass surgery

gastric bypass

Intervention Type PROCEDURE

Roux-en-Y gastric bypass

gastric banding

morbidly obese subjects undergoing laparoscopic gastric banding surgery

gastric banding

Intervention Type PROCEDURE

laparoscopic adjustable gastric banding

sleeve gastrectomy

morbidly obese subjects undergoing sleeve gastrectomy

sleeve gastrectomy

Intervention Type PROCEDURE

vertical sleeve gastrectomy

Interventions

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gastric bypass

Roux-en-Y gastric bypass

Intervention Type PROCEDURE

gastric banding

laparoscopic adjustable gastric banding

Intervention Type PROCEDURE

sleeve gastrectomy

vertical sleeve gastrectomy

Intervention Type PROCEDURE

Other Intervention Names

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Roux-en-Y gastric bypass lap band gastric sleeve

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ethicon Endo-Surgery

INDUSTRY

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samuel Klein, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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Yoshino J, Patterson BW, Klein S. Adipose Tissue CTGF Expression is Associated with Adiposity and Insulin Resistance in Humans. Obesity (Silver Spring). 2019 Jun;27(6):957-962. doi: 10.1002/oby.22463. Epub 2019 Apr 19.

Reference Type DERIVED
PMID: 31004409 (View on PubMed)

Harris LLS, Smith GI, Mittendorfer B, Eagon JC, Okunade AL, Patterson BW, Klein S. Roux-en-Y Gastric Bypass Surgery Has Unique Effects on Postprandial FGF21 but Not FGF19 Secretion. J Clin Endocrinol Metab. 2017 Oct 1;102(10):3858-3864. doi: 10.1210/jc.2017-01295.

Reference Type DERIVED
PMID: 28938478 (View on PubMed)

Magkos F, Bradley D, Eagon JC, Patterson BW, Klein S. Effect of Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding on gastrointestinal metabolism of ingested glucose. Am J Clin Nutr. 2016 Jan;103(1):61-5. doi: 10.3945/ajcn.115.116111. Epub 2015 Nov 25.

Reference Type DERIVED
PMID: 26607940 (View on PubMed)

Bradley D, Magkos F, Eagon JC, Varela JE, Gastaldelli A, Okunade AL, Patterson BW, Klein S. Matched weight loss induced by sleeve gastrectomy or gastric bypass similarly improves metabolic function in obese subjects. Obesity (Silver Spring). 2014 Sep;22(9):2026-31. doi: 10.1002/oby.20803. Epub 2014 May 28.

Reference Type DERIVED
PMID: 24891156 (View on PubMed)

Magkos F, Bradley D, Schweitzer GG, Finck BN, Eagon JC, Ilkayeva O, Newgard CB, Klein S. Effect of Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding on branched-chain amino acid metabolism. Diabetes. 2013 Aug;62(8):2757-61. doi: 10.2337/db13-0185. Epub 2013 Apr 22.

Reference Type DERIVED
PMID: 23610059 (View on PubMed)

Kohli R, Bradley D, Setchell KD, Eagon JC, Abumrad N, Klein S. Weight loss induced by Roux-en-Y gastric bypass but not laparoscopic adjustable gastric banding increases circulating bile acids. J Clin Endocrinol Metab. 2013 Apr;98(4):E708-12. doi: 10.1210/jc.2012-3736. Epub 2013 Mar 1.

Reference Type DERIVED
PMID: 23457410 (View on PubMed)

Other Identifiers

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09-0175

Identifier Type: -

Identifier Source: org_study_id

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