Clinical trial NCT00981500: Glucose Homeostasis Pre and Post Bariatric Surgery
Official title: Effect of Bariatric Surgery-induced Weight Loss on Glucose Homeostasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Morbid Obesity
Keywords: obesity
gastric bypass
gastric banding
weight loss
insulin sensitivity
sleeve gastrectomy
fibroblast growth factor 21
fibroblast growth factor 19
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Ethicon Endo-Surgery
First posted: 2009-09-22
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 20 (per surgical group) morbidly obese (BMI ≥ 35 kg/m²) subjects scheduled for bariatric surgical procedures will participate in this study.

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.

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

Primary outcomes:
measure: The effect of bariatric surgery-induced weight loss (Roux-en-Y gastric bypass, sleeve gastrectomy, and laparoscopic adjustable banding) on insulin action
timeFrame: at 20% weight loss post surgery
Secondary outcomes:
measure: 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
timeFrame: at 20% weight loss post surgery
measure: Determine the effect of bariatric surgery induced weight loss (Roux-en-Y gastric bypass, sleeve gastrectomy, and laparoscopic adjustable gastric banding) on gut microbiota.
timeFrame: at 20% weight loss post surgery
measure: Identify host genes that co-vary with an altered metagenome in obese individuals that undergo bariatric surgery
timeFrame: at 20% weight loss post surgery.
measure: Investigate how the metagenome is affected by bariatric surgery procedures leading to weight reduction
timeFrame: at 20% weight loss post surgery
measure: 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.
timeFrame: at 20% weight loss post surgery
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Samuel Klein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.