Overview

This trial is active, not recruiting.

Condition obesity
Treatment roux-en-y gastric bypass surgery or sleeve surgery
Sponsor University of Copenhagen
Collaborator Bariatric Clinic, Department of Surgery, Køge Hospital, Denmark
Start date March 2014
End date April 2017
Trial size 55 participants
Trial identifier NCT02070081, GO Bypass

Summary

The overall aim is to study the multiple factors determining the variation of weight loss after Roux-en-Y Gastric Bypass (RYGB) and Sleeve surgery.

The specific aims are to evaluate:

a) what explains the large individual differences in weight loss seen after RYGB and Sleeve surgery, b) if it is possible pre-operatively to identify which patients will not obtain beneficial effects of bariatric surgery in relation to weight loss and quality of life and c) if patients in need of improved care can be identified pre- and/or early post-operatively.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
roux-en-y gastric bypass surgery or sleeve surgery

Primary Outcomes

Measure
Weight loss
time frame: 3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively

Secondary Outcomes

Measure
Metabolic profile
time frame: 3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively
Physical activity
time frame: 3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively
Appetite sensation
time frame: 3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively
Taste preferences and taste perception
time frame: 3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively
Mental health
time frame: 3 month preoperatively, 6 month postoperatively and 18 month postoperatively
Social resources
time frame: 3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively
Gut microbiota
time frame: 1 week preoperatively, 6 month postoperatively
Appetite-regulating hormones
time frame: 3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively
Bile acids and fibroblast growth factors
time frame: 3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively
Genetics
time frame: 3 month preoperatively
Body composition
time frame: 3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively
Cortisol
time frame: 3 month preoperatively and 18 month postoperatively
Neural activity in reward-processing brain centers
time frame: preoperatively and 6 month postoperatively
Rewarding value of food
time frame: preoperatively and 6 month postoperatively

Eligibility Criteria

Male or female participants from 25 years up to 65 years old.

Inclusion Criteria: - All patients approved for bariatric surgery at Bariatric Clinic, Køge Hospital, Denmark Exclusion Criteria: - Inability to comply with the study protocol

Additional Information

Official title Patient Profiling for Successful Weight Loss After Gastric Bypass or Sleeve Surgery
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of Copenhagen.