Weight Loss Following Gastric Bypass or Sleeve Surgery

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Procedure: Roux-en-Y gastric bypass surgery or sleeve surgery

• Registration Number: NCT02070081
• Lead Sponsor: University of Copenhagen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-18
• Study First Submitted QC: 2014-02-20
• Study First Posted: 2014-02-24
• Study Start: 2014-03
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-22
• Last Update Posted: 2019-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• All patients approved for bariatric surgery at Bariatric Clinic, Køge Hospital, Denmark

Exclusion Criteria

• Inability to comply with the study protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgery	Roux-en-Y gastric bypass surgery or sleeve surgery	-

Primary Outcome Measures

Name	Time	Method
Weight loss	3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively

Secondary Outcome Measures

Name	Time	Method
Social resources	3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively
Bile acids and fibroblast growth factors	3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively
Taste preferences and taste perception	3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively	Sensory tests, picture displays (all visits) and an ad libitum test meals (3 months preoperatively and 6 months postoperatively) are used to investigate changes in taste and food preferences (liking and wanting) and taste perception
Genetics	3 month preoperatively
Gut microbiota	1 week preoperatively, 6 month postoperatively
Appetite-regulating hormones	3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively	GLP-1, PYY, leptin, ghrelin, OXM, CCK, glicentin
Physical activity	3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively
Mental health	3 month preoperatively, 6 month postoperatively and 18 month postoperatively
Body composition	3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively	By DXA scans
Metabolic profile	3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively	Insulin, glucose, C-peptide, GIP, glucagon, TSH, thyroid hormones, vitamin D and blood lipids
Appetite sensation	3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively	Following a test meal with the use of visual analogue scales (VAS)
Cortisol	3 month preoperatively and 18 month postoperatively	Measured in hair
Rewarding value of food	preoperatively and 6 month postoperatively	Behavioral test
Neural activity in reward-processing brain centers	preoperatively and 6 month postoperatively	By functional magnetic resonance imaging (fmri)

Trial Locations

Locations (1)

Faculty of Science, NEXS; 🇩🇰 Frederiksberg, Denmark