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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Karolinska Institutet
Danderyd Hospital
Ersta Hospital, Sweden
Karolinska University Hospital
Information provided by (Responsible Party):
Erik Näslund, Karolinska Institutet Identifier:
First received: November 12, 2012
Last updated: August 23, 2015
Last verified: August 2015
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
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:

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: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Gastric bypass surgery and non-obese controls undergoing cholecystectomy
Procedure: Gastric bypass or cholecystectomy


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

Inclusion Criteria:

  • laparoscopic gastric by-pass with BMI greater than 35

Exclusion Criteria:

  • unable to understand swedish
  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 identifier: NCT01736384

Contact: Erik Näslund, Professor +76 (0) 8 123 550 17
Contact: Anders Thorell, Ass. Prof. +46 (0) 8 714 6541 ext 6541

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

No publications provided

Responsible Party: Erik Näslund, Professor, Karolinska Institutet Identifier: NCT01736384     History of Changes
Other Study ID Numbers: 2008/1010-31/3 
Study First Received: November 12, 2012
Last Updated: August 23, 2015
Health Authority: Sweden: The National Board of Health and Welfare processed this record on February 04, 2016