Weight Loss Following Gastric Bypass or Sleeve Surgery

Obesity Clinical Trial

Official title:

Patient Profiling for Successful Weight Loss After Gastric Bypass or Sleeve Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02070081
• Other study ID #: GO Bypass
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: April 2017

Study information

• Verified date: May 2019
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Inability to comply with the study protocol

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
Denmark	Faculty of Science, NEXS	Frederiksberg

Sponsors (3)

Lead Sponsor	Collaborator
University of Copenhagen	Bariatric Clinic, Department of Surgery, Køge Hospital, Denmark, The Danish Research Centre for Magnetic Resonance, Hvidovre Hospital, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss		3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively
Secondary	Metabolic profile	Insulin, glucose, C-peptide, GIP, glucagon, TSH, thyroid hormones, vitamin D and blood lipids	3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively
Secondary	Physical activity		3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively
Secondary	Appetite sensation	Following a test meal with the use of visual analogue scales (VAS)	3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively
Secondary	Taste preferences and taste perception	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	3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively
Secondary	Mental health		3 month preoperatively, 6 month postoperatively and 18 month postoperatively
Secondary	Social resources		3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively
Secondary	Gut microbiota		1 week preoperatively, 6 month postoperatively
Secondary	Appetite-regulating hormones	GLP-1, PYY, leptin, ghrelin, OXM, CCK, glicentin	3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively
Secondary	Bile acids and fibroblast growth factors		3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively
Secondary	Genetics		3 month preoperatively
Secondary	Body composition	By DXA scans	3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively
Secondary	Cortisol	Measured in hair	3 month preoperatively and 18 month postoperatively
Secondary	Neural activity in reward-processing brain centers	By functional magnetic resonance imaging (fmri)	preoperatively and 6 month postoperatively
Secondary	Rewarding value of food	Behavioral test	preoperatively and 6 month postoperatively