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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01736384
First Posted: November 29, 2012
Last Update Posted: March 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Danderyd Hospital
Ersta Hospital, Sweden
Karolinska University Hospital
Information provided by (Responsible Party):
Erik Näslund, Karolinska Institutet
  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: Observational Model: Other
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 Erik Näslund, Karolinska Institutet:

Primary Outcome Measures:
  • Genetic markers [ Time Frame: day of surgery and 1 and 2 years after surgery ]
    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 ]
    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 ]
    Blood samples taken before surgery

  • Genexpression and comorbid disease [ Time Frame: At time of bariatric surgery and 1-2 years postoperatively ]
    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

Enrollment: 2000
Study Start Date: February 2009
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01736384


Locations
Sweden
Karolinska Institutet, Ersta Hospital
Stockholm, Sweden, SE-116 91
Karolinska Institutet, Danderyds Hospital
Stockholm, Sweden, SE-182 88
Karolinska University Hospital
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

Responsible Party: Erik Näslund, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01736384     History of Changes
Other Study ID Numbers: 2008/1010-31/3
First Submitted: November 12, 2012
First Posted: November 29, 2012
Last Update Posted: March 3, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms