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

February 27, 2020 updated by: Erik Näslund, Karolinska Institutet

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Obesity

Description

Inclusion Criteria:

  • laparoscopic gastric by-pass with BMI greater than 35

Exclusion Criteria:

  • unable to understand swedish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Obesity
Gastric bypass surgery and non-obese controls undergoing cholecystectomy
Procedure: Gastric bypass or cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
day of surgery and 1 and 2 years after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
day of surgery and at 1 and 2 years postoperatively
Previous viral infection
Time Frame: At time of surgery
Blood samples taken before surgery
At time of 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
At time of bariatric surgery and 1-2 years postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Karolinska University Hospital
Danderyd Hospital
Ersta Hospital, Sweden

Investigators

  • Principal Investigator: Erik Näslund, Professor, Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2009

Primary Completion (Actual)

February 1, 2020

Study Completion (Actual)

February 1, 2020

Study Registration Dates

First Submitted

November 12, 2012

First Submitted That Met QC Criteria

November 26, 2012

First Posted (Estimate)

November 29, 2012

Study Record Updates

Last Update Posted (Actual)

February 28, 2020

Last Update Submitted That Met QC Criteria

February 27, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008/1010-31/3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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