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

Obesity Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01736384
• Other study ID #: 2008/1010-31/3
• Status: Completed
• Start date: February 2009
• Est. completion date: February 2020

Study information

• Verified date: February 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• laparoscopic gastric by-pass with BMI greater than 35

Exclusion Criteria:

• unable to understand swedish

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Procedure:
• Gastric bypass or cholecystectomy

Locations

Country	Name	City	State
Sweden	Karolinska Institutet, Danderyds Hospital	Stockholm
Sweden	Karolinska Institutet, Ersta Hospital	Stockholm
Sweden	Karolinska University Hospital	Stockholm

Sponsors (4)

Lead Sponsor	Collaborator
Karolinska Institutet	Danderyd Hospital, Ersta Hospital, Sweden, Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genetic markers	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	Lipid and protein patterns in plasma and tissues	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
Secondary	Previous viral infection	Blood samples taken before surgery	At time of surgery
Secondary	Genexpression and comorbid disease	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