NCT01736384

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2009

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 29, 2012

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

February 28, 2020

Status Verified

February 1, 2020

Enrollment Period

11 years

First QC Date

November 12, 2012

Last Update Submit

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

Procedure: Gastric bypass or cholecystectomy

Interventions

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Study Sites (3)

Karolinska Institutet, Ersta Hospital

Stockholm, SE-116 91, Sweden

Location

Karolinska Institutet, Danderyds Hospital

Stockholm, SE-182 88, Sweden

Location

Karolinska University Hospital

Stockholm, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue biopies, liver and subcutaneous and omental fat Whole blood EDTA-plasma Serum

MeSH Terms

Conditions

Obesity

Interventions

Gastric BypassCholecystectomy

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical ProceduresBiliary Tract Surgical Procedures

Study Officials

  • Erik Näslund, Professor

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

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

Locations