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Glucose Homeostasis Pre and Post Bariatric Surgery (RB)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Ethicon Endo-Surgery
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00981500
First received: September 18, 2009
Last updated: December 27, 2016
Last verified: December 2016
  Purpose
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.

Condition Intervention
Morbid Obesity Procedure: gastric bypass Procedure: gastric banding Procedure: sleeve gastrectomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Bariatric Surgery-induced Weight Loss on Glucose Homeostasis

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]
  • 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 ]
  • 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. ]
  • Investigate how the metagenome is affected by bariatric surgery procedures leading to weight reduction [ Time Frame: 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. [ Time Frame: at 20% weight loss post surgery ]

Biospecimen Retention:   Samples With DNA
plasma, tongue tissue, muscle tissue, fat tissue,liver tissue, colon tissue, stool

Estimated Enrollment: 60
Study Start Date: December 2009
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Gastric Bypass
morbidly obese subjects undergoing gastric bypass surgery
Procedure: gastric bypass
Roux-en-Y gastric bypass
Other Name: Roux-en-Y gastric bypass
gastric banding
morbidly obese subjects undergoing laparoscopic gastric banding surgery
Procedure: gastric banding
laparoscopic adjustable gastric banding
Other Name: lap band
sleeve gastrectomy
morbidly obese subjects undergoing sleeve gastrectomy
Procedure: sleeve gastrectomy
vertical sleeve gastrectomy
Other Name: gastric sleeve

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

Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00981500

Locations
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Ethicon Endo-Surgery
Investigators
Principal Investigator: Samuel Klein, MD Washington University School of Medicine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00981500     History of Changes
Other Study ID Numbers: 09-0175
Study First Received: September 18, 2009
Last Updated: December 27, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Washington University School of Medicine:
obesity
gastric bypass
gastric banding
weight loss
insulin sensitivity
sleeve gastrectomy
fibroblast growth factor 21
fibroblast growth factor 19

Additional relevant MeSH terms:
Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 22, 2017