NCT00981500

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 22, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

4.5 years

First QC Date

September 18, 2009

Last Update Submit

August 9, 2018

Conditions

Morbid Obesity

Keywords

obesitygastric bypassgastric bandingweight lossinsulin sensitivitysleeve gastrectomyfibroblast growth factor 21fibroblast growth factor 19

Outcome Measures

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

    at 20% weight loss post surgery

Secondary Outcomes (5)

  • 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

  • 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

  • Identify host genes that co-vary with an altered metagenome in obese individuals that undergo bariatric surgery

    at 20% weight loss post surgery.

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

    at 20% weight loss post surgery

  • 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

Study Arms (3)

Gastric Bypass

morbidly obese subjects undergoing gastric bypass surgery

Procedure: gastric bypass

gastric banding

morbidly obese subjects undergoing laparoscopic gastric banding surgery

Procedure: gastric banding

sleeve gastrectomy

morbidly obese subjects undergoing sleeve gastrectomy

Procedure: sleeve gastrectomy

Interventions

gastric bypassPROCEDURE

Roux-en-Y gastric bypass

Also known as: Roux-en-Y gastric bypass
Gastric Bypass
gastric bandingPROCEDURE

laparoscopic adjustable gastric banding

Also known as: lap band
gastric banding
sleeve gastrectomyPROCEDURE

vertical sleeve gastrectomy

Also known as: gastric sleeve
sleeve gastrectomy

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • BMI ≥ 35 kg/m²
  • on stable dose of medications for at least 4 weeks before the pre-surgery metabolic studies

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (6)

  • 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.

    PMID: 31004409DERIVED

  • 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.

    PMID: 28938478DERIVED

  • 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.

    PMID: 26607940DERIVED

  • 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.

    PMID: 24891156DERIVED

  • 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.

    PMID: 23610059DERIVED

  • 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.

    PMID: 23457410DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

plasma, tongue tissue, muscle tissue, fat tissue,liver tissue, colon tissue, stool

MeSH Terms

Conditions

Obesity, MorbidObesityWeight LossInsulin Resistance

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Officials

  • Samuel Klein, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2009

First Posted

September 22, 2009

Study Start

December 1, 2009

Primary Completion

June 1, 2014

Study Completion

June 1, 2018

Last Updated

August 10, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)