Clinical Trials Washington University, St. Louis

This was still open on 7 October.  If any of you lurkers are interested read through and note the exclusions and contact person.  It won't stay open long. 

Jackie
********************************************

http://clinicaltrials.gov/ct2/show/NCT00981500?term=gastric+ bypass&cntry1=NA%3AUS&rank=26

Study 26 of 119 for search of:gastric bypass | United States

Glucose Homeostasis and Taste Perception Pre and Post Bariatric Surgery (RB)

This study is currently recruiting participants.
Verified by Washington University School of Medicine, May 2010
First Received: September 18, 2009   Last Updated: May 27, 2010   History of Changes
Sponsor: Washington University School of Medicine
Collaborator: Ethicon Endo-Surgery

Information provided by: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00981500

  Purpose
The investigators wish to study the effects of three forms of bariatric surgery, gastric bypass, lap banding, and sleeve gastrectomy. The surgery itself is a clinical procedure that is not under investigation. We are doing pre and post surgery testing to provide a better understanding of the effect of bariatric surgery-induced weight loss on insulin action, pancreatic beta cell function and taste perception. The investigators hypothesize that weight loss induced by gastric bypass surgery will have greater effects on insulin sensitivity, beta cell function, taste perception and expression of genes involved in taste perception than weight loss induced by gastric banding or sleeve gastrectomy.

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 and Taste Perception

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines Obesity Taste and Smell Disorders Weight Control Weight Loss Surgery
U.S. FDA Resources

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

Primary Outcome Measures:
Effects of bariatric surgery on insulin action in liver, skeletal muscle and adipose tissue [ Time Frame: at 15 - 20% weight loss post surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
The effect of weight loss on pancreatic beta cell response [ Time Frame: at 15 - 20% weight loss post surgery ] [ Designated as safety issue: No ]

the effect of weight loss and upper GI tract diversion on taste perception [ Time Frame: at 15 - 20% weight loss post surgery ] [ Designated as safety issue: No ]

Determine the relationship between taste perception and taste receptor expression in tongue and gut. [ Time Frame: at 15 - 20% weight loss post surgery ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

plasma, tongue tissue, muscle tissue, fat tissue,

Estimated Enrollment:30
Study Start Date:September 2009
Estimated Study Completion Date:September 2013
Estimated Primary Completion Date:September 2013 (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
gastric banding
morbidly obese subjects undergoing laparoscopic gastric banding surgery Procedure: gastric banding
laparoscopic adjustable gastric banding
sleeve gastrectomy
subjects undergoing sleeve gastrectomy Procedure: sleeve gastrectomy
sleeve gastrectomy is a surgical weight-loss procedure in which the stomach is reduced to about 15% of its original size, by surgical removal of a large portion of the stomach, following the major curve.

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 Roux-en-Y gastric bypass (RYGB) surgery has led to the hypothesis that bypassing the upper gastrointestinal (GI) tract has specific beneficial effects on glucose homeostasis beyond weight loss alone. However, this hypothesis has never been adequately evaluated in human subjects. In addition, it has been observed that bariatric surgery-induced weight loss is associated with changes in taste perception, which could also affect glucose metabolism by affecting food choices. However, it is not known whether weight loss or upper gastrointestinal tract diversion have independent effects on taste perception in obese persons. 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, pancreatic beta cell function and taste perception. We hypothesize that weight loss induced by RYGB surgery will have greater effects on insulin sensitivity, beta cell function, taste perception and expression of genes involved in taste perception than weight loss induced by laparoscopic adjustable gastric banding (LAGB) or sleeve gastrectomy.
  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population
A total of 30 morbidly obese (BMI ≥ 40 kg/m2) subjects scheduled for bariatric surgical procedures will participate in this study.
Criteria

Inclusion Criteria:
BMI > 40
on stable dose of medications for at least 4 weeks before the pre-surgery metabolic studies

Exclusion Criteria:
smokers
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 or taste
severe organ dysfunction
  Contacts and Locations

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

Contacts
Contact: Courtney Tiemann, [email protected]

Locations
United States, Missouri
Washington University School of MedicineRecruiting
Saint Louis, Missouri, United States, 63110
Contact: Courtney Tiemann, R.D.     314-362-8250     [email protected]    
Principal Investigator: Samuel Klein, M.D.            

Sponsors and Collaborators
Washington University School of Medicine
Ethicon Endo-Surgery
Investigators
Principal Investigator:Samuel Klein, MDWashington University School of Medicine

  More Information

No publications provided

Responsible Party:Washington University ( Samuel Klein, Professor of Medicine )
ClinicalTrials.gov Identifier:NCT00981500     History of Changes
Other Study ID Numbers:09-0175
Study First Received:September 18, 2009
Last Updated:May 27, 2010
Health Authority:United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
obesity
gastric bypass
gastric banding
weight loss
taste perception
insulin sensitivity

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

ClinicalTrials.gov processed this record on October 07, 2010