search
Back to results

Weight Loss Following Gastric Bypass or Sleeve Surgery

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Roux-en-Y gastric bypass surgery or sleeve surgery
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Bariatric surgery

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Inability to comply with the study protocol

Sites / Locations

  • Faculty of Science, NEXS

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Surgery

Arm Description

Outcomes

Primary Outcome Measures

Weight loss

Secondary Outcome Measures

Metabolic profile
Insulin, glucose, C-peptide, GIP, glucagon, TSH, thyroid hormones, vitamin D and blood lipids
Physical activity
Appetite sensation
Following a test meal with the use of visual analogue scales (VAS)
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
Mental health
Social resources
Gut microbiota
Appetite-regulating hormones
GLP-1, PYY, leptin, ghrelin, OXM, CCK, glicentin
Bile acids and fibroblast growth factors
Genetics
Body composition
By DXA scans
Cortisol
Measured in hair
Neural activity in reward-processing brain centers
By functional magnetic resonance imaging (fmri)
Rewarding value of food
Behavioral test

Full Information

First Posted
February 18, 2014
Last Updated
May 22, 2019
Sponsor
University of Copenhagen
Collaborators
Bariatric Clinic, Department of Surgery, Køge Hospital, Denmark, The Danish Research Centre for Magnetic Resonance, Hvidovre Hospital, Denmark
search

1. Study Identification

Unique Protocol Identification Number
NCT02070081
Brief Title
Weight Loss Following Gastric Bypass or Sleeve Surgery
Official Title
Patient Profiling for Successful Weight Loss After Gastric Bypass or Sleeve Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
March 2014 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Bariatric Clinic, Department of Surgery, Køge Hospital, Denmark, The Danish Research Centre for Magnetic Resonance, Hvidovre Hospital, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Bariatric surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients approved for bariatric surgery at Bariatric Clinic, Køge Hospital, Denmark Exclusion Criteria: Inability to comply with the study protocol
Facility Information:
Facility Name
Faculty of Science, NEXS
City
Frederiksberg
ZIP/Postal Code
1958
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
32016415
Citation
Nielsen MS, Ritz C, Wewer Albrechtsen NJ, Holst JJ, le Roux CW, Sjodin A. Oxyntomodulin and Glicentin May Predict the Effect of Bariatric Surgery on Food Preferences and Weight Loss. J Clin Endocrinol Metab. 2020 Apr 1;105(4):dgaa061. doi: 10.1210/clinem/dgaa061.
Results Reference
derived
PubMed Identifier
31556242
Citation
Nielsen MS, Andersen INSK, Lange B, Ritz C, le Roux CW, Schmidt JB, Sjodin A, Bredie WLP. Bariatric Surgery Leads to Short-Term Effects on Sweet Taste Sensitivity and Hedonic Evaluation of Fatty Food Stimuli. Obesity (Silver Spring). 2019 Nov;27(11):1796-1804. doi: 10.1002/oby.22589. Epub 2019 Sep 26.
Results Reference
derived
PubMed Identifier
30722827
Citation
Taekker L, Lunn S. The effect of mental health on weight loss after bariatric surgery. Dan Med J. 2019 Feb;66(2):A5532.
Results Reference
derived
PubMed Identifier
30421858
Citation
Sondergaard Nielsen M, Rasmussen S, Just Christensen B, Ritz C, le Roux CW, Berg Schmidt J, Sjodin A. Bariatric Surgery Does Not Affect Food Preferences, but Individual Changes in Food Preferences May Predict Weight Loss. Obesity (Silver Spring). 2018 Dec;26(12):1879-1887. doi: 10.1002/oby.22272. Epub 2018 Nov 13.
Results Reference
derived
PubMed Identifier
30023446
Citation
Christensen BJ, Schmidt JB, Nielsen MS, Taekker L, Holm L, Lunn S, Bredie WLP, Ritz C, Holst JJ, Hansen T, Hilbert A, le Roux CW, Hulme OJ, Siebner H, Morville T, Naver L, Floyd AK, Sjodin A. Patient profiling for success after weight loss surgery (GO Bypass study): An interdisciplinary study protocol. Contemp Clin Trials Commun. 2018 Feb 17;10:121-130. doi: 10.1016/j.conctc.2018.02.002. eCollection 2018 Jun.
Results Reference
derived
PubMed Identifier
28411313
Citation
Nielsen MS, Christensen BJ, Ritz C, Rasmussen S, Hansen TT, Bredie WLP, le Roux CW, Sjodin A, Schmidt JB. Roux-En-Y Gastric Bypass and Sleeve Gastrectomy Does Not Affect Food Preferences When Assessed by an Ad libitum Buffet Meal. Obes Surg. 2017 Oct;27(10):2599-2605. doi: 10.1007/s11695-017-2678-6.
Results Reference
derived

Learn more about this trial

Weight Loss Following Gastric Bypass or Sleeve Surgery

We'll reach out to this number within 24 hrs