Can Genetic Markers Predict Weight Loss After Gastric By-pass Surgery
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.
1 other identifier
observational
2,000
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2009
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 12, 2012
CompletedFirst Posted
Study publicly available on registry
November 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedFebruary 28, 2020
February 1, 2020
11 years
November 12, 2012
February 27, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Lipid and protein patterns in plasma and tissues
day of surgery and at 1 and 2 years postoperatively
Previous viral infection
At time of surgery
Genexpression and comorbid disease
At time of bariatric surgery and 1-2 years postoperatively
Study Arms (1)
Obesity
Gastric bypass surgery and non-obese controls undergoing cholecystectomy
Interventions
Eligibility Criteria
Obesity
You may qualify if:
- laparoscopic gastric by-pass with BMI greater than 35
You may not qualify if:
- unable to understand swedish
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska Institutetlead
- Danderyd Hospitalcollaborator
- Ersta Hospital, Swedencollaborator
- Karolinska University Hospitalcollaborator
Study Sites (3)
Karolinska Institutet, Ersta Hospital
Stockholm, SE-116 91, Sweden
Karolinska Institutet, Danderyds Hospital
Stockholm, SE-182 88, Sweden
Karolinska University Hospital
Stockholm, Sweden
Biospecimen
Tissue biopies, liver and subcutaneous and omental fat Whole blood EDTA-plasma Serum
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erik Näslund, Professor
Karolinska Institutet
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 12, 2012
First Posted
November 29, 2012
Study Start
February 1, 2009
Primary Completion
February 1, 2020
Study Completion
February 1, 2020
Last Updated
February 28, 2020
Record last verified: 2020-02