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Can Genetic Markers Predict Weight Loss After Gastric By-pass Surgery

This study is currently recruiting participants.
Verified November 2012 by Karolinska Institutet
Sponsor:
Collaborators:
Danderyd Hospital
Ersta Hospital, Sweden
Karolinska University Hospital
Information provided by (Responsible Party):
Erik Näslund, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01736384
First received: November 12, 2012
Last updated: November 26, 2012
Last verified: November 2012
History of Changes
  Purpose

There is a variability in weight loss after gastric bypass surgery for obesity despite a standardised surgical procedure. This study aims to investigate if genetic markers can predict outcome after gastric by-pass surgery in treatment of obesity. The investigators will also study if adenovirus infection can influence the outcome after surgery. In a subgroup of patients, hormonal changes after gastric by-pass surgery will be assessed. Lipid and protein patterns will be assessed in plasma and tissues. Omental and subcutaneous fat as well as liver biopsies and whole blood are stored in a biobank. The same tissues will be collected from non-obese controls undergoing gallbladder surgery.


Condition Intervention
Obesity
 Procedure: Gastric bypass or cholecystectomy

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Can Genetic Changes Predict Weight Loss and Outcome After Bariatric Surgery and Can it Related to Virus Infection and Function of Liver and Adipose Tissue as Well as Lipid and Protein Profiles.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Genetic markers [ Time Frame: day of surgery and 1 and 2 years after surgery ] [ Designated as safety issue: No ]
    Blood samples and tissue biopsies taken at the time of surgery and at follow-up.


Secondary Outcome Measures:
  • Lipid and protein patterns in plasma and tissues [ Time Frame: day of surgery and at 1 and 2 years postoperatively ] [ Designated as safety issue: No ]
    Blood samples taken and tissue biopsies taken at the time of surgery and at follow-up

  • Previous viral infection [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]
    Blood samples taken before surgery

  • Genexpression and comorbid disease [ Time Frame: At time of bariatric surgery and 1-2 years postoperatively ] [ Designated as safety issue: No ]
    Gene expression studies in tissue biopsies and whole blood at time of surgery and follow-up


Biospecimen Retention:   Samples With DNA

Tissue biopies, liver and subcutaneous and omental fat Whole blood EDTA-plasma Serum


Estimated Enrollment: 3000
Study Start Date: February 2009
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Obesity
Gastric bypass surgery and non-obese controls undergoing cholecystectomy
 Procedure: Gastric bypass or cholecystectomy

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Obesity

Criteria

Inclusion Criteria:

  • laparoscopic gastric by-pass with BMI greater than 35

Exclusion Criteria:

  • unable to understand swedish
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01736384

Contacts
Contact: Erik Näslund, Professor +76 (0) 8 123 550 17 erik.naslund@ki.se
Contact: Anders Thorell, Ass. Prof. +46 (0) 8 714 6541 ext 6541 anders.thorell@erstadiakoni.se

Locations
Sweden
Karolinska Institutet, Danderyds Hospital Recruiting
Stockholm, Sweden, SE-182 88
Contact: Erik Näslund, professor     +46 (0) 8 123 550 17     erik.naslund@ki.se    
Principal Investigator: Erik Näslund, Professor            
Karolinska Institutet, Ersta Hospital Recruiting
Stockholm, Sweden, SE-116 91
Contact: Anders Thorell, Ass. prof.     +46 (0) 8 7146541 ext 6541     anders.thorell@erstadiakoni.se    
Sub-Investigator: Anders Thorell, Ass. Prof.            
Karolinska University Hospital Active, not recruiting
Stockholm, Sweden
Sponsors and Collaborators
Karolinska Institutet
Danderyd Hospital
Ersta Hospital, Sweden
Karolinska University Hospital
Investigators
Principal Investigator: Erik Näslund, Professor Karolinska Institutet
  More Information

No publications provided

Responsible Party: Erik Näslund, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01736384     History of Changes
Other Study ID Numbers: 2008/1010-31/3
Study First Received: November 12, 2012
Last Updated: November 26, 2012
Health Authority: Sweden: The National Board of Health and Welfare

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 16, 2013