Weight Loss Following Gastric Bypass or Sleeve Surgery

May 22, 2019 updated by: Arne Astrup, University of Copenhagen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Frederiksberg, Denmark, 1958
        • Faculty of Science, NEXS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Inability to comply with the study protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surgery
Procedure: Roux-en-Y gastric bypass surgery or sleeve surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight loss
Time Frame: 3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively
3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic profile
Time Frame: 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
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
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
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
Taste preferences and taste perception
Time Frame: 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
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
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
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
1 week preoperatively, 6 month postoperatively
Appetite-regulating hormones
Time Frame: 3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively
GLP-1, PYY, leptin, ghrelin, OXM, CCK, glicentin
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
3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively
Genetics
Time Frame: 3 month preoperatively
3 month preoperatively
Body composition
Time Frame: 3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively
By DXA scans
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
Measured in hair
3 month preoperatively and 18 month postoperatively
Neural activity in reward-processing brain centers
Time Frame: preoperatively and 6 month postoperatively
By functional magnetic resonance imaging (fmri)
preoperatively and 6 month postoperatively
Rewarding value of food
Time Frame: preoperatively and 6 month postoperatively
Behavioral test
preoperatively and 6 month postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

Bariatric Clinic, Department of Surgery, Køge Hospital, Denmark
The Danish Research Centre for Magnetic Resonance, Hvidovre Hospital, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2014

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

February 18, 2014

First Submitted That Met QC Criteria

February 20, 2014

First Posted (Estimate)

February 24, 2014

Study Record Updates

Last Update Posted (Actual)

May 24, 2019

Last Update Submitted That Met QC Criteria

May 22, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO Bypass

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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