Overview

This trial is active, not recruiting.

Conditions obesity, non-obese controls
Treatments obese, control group
Sponsor Karolinska Institutet
Collaborator Danderyd Hospital
Start date November 2011
End date December 2017
Trial size 500 participants
Trial identifier NCT01727245, 2011/1002-31/1

Summary

We want to asses the role of adipose tissue for metabolic complications to obesity before and after weight loss (surgery).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose basic science
Arm
(Other)
Obese patients undergoing gastric by-pass surgery
obese
gastric bypass
(Other)
Cholecystectomy and anti-reflux surgery
control group
Cholecystectomy and anti-reflux surgery

Primary Outcomes

Measure
Insulin sensitivity, adipose tissue function and gene function
time frame: two years after surgery

Secondary Outcomes

Measure
Body composition
time frame: two years after surgery
Vascular function
time frame: two years after surgery

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion Criteria obese: - Bariatric surgery with laparoscopic gastric by-pass Exclusion Criteria obese: - diabetes mellitus typ 2 with insulin treatment and/or glitazones - oral or parenteral steroid treatment - complicated psychiatric disease - Warfarin use Inclusion Criteria non-obese controls: - BMI under 30 Exclusion Criteria non-obese controls: - diabetes - oral or parenteral steroids treatment - complicated psychiatric disease - Warfarins use

Additional Information

Official title The Role of Adipose Tissue in Atherogenic Conditions in Man - Mechanisms and Interventions
Principal investigator Erik Näslund, Prof.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Karolinska Institutet.