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

Completed

• Conditions: Obesity
• Interventions: Procedure: Gastric bypass or cholecystectomy

• Registration Number: NCT01736384
• Lead Sponsor: Karolinska Institutet

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2012-11-12
• Study First Submitted QC: 2012-11-26
• Study First Posted: 2012-11-29
• Status Verified: 2020-02
• Primary Completion: 2020-02
• Study Completion: 2020-02
• Last Update Submitted: 2020-02-27
• Last Update Posted: 2020-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• laparoscopic gastric by-pass with BMI greater than 35

Exclusion Criteria

• unable to understand swedish

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Obesity	Gastric bypass or cholecystectomy	Gastric bypass surgery and non-obese controls undergoing cholecystectomy

Primary Outcome Measures

Name	Time	Method
Genetic markers	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

Name	Time	Method
Genexpression and comorbid disease	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
Lipid and protein patterns in plasma and tissues	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	At time of surgery	Blood samples taken before surgery

Trial Locations

Locations (3)

Karolinska Institutet, Danderyds Hospital; 🇸🇪 Stockholm, Sweden

Karolinska Institutet, Ersta Hospital; 🇸🇪 Stockholm, Sweden

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden