ObesityNCT02070081
Weight Loss Following Gastric Bypass or Sleeve Surgery
A study testing Roux-en-Y gastric bypass surgery or sleeve surgery in people with Obesity, run by University of Copenhagen at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Roux-en-Y gastric bypass surgery or sleeve surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2014to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients approved for bariatric surgery at Bariatric Clinic, Køge Hospital, Denmark
Who cannot join
- Inability to comply with the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- 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.
- Conditions
- Obesity
- Being tested
- Roux-en-Y gastric bypass surgery or sleeve surgery
- Keywords
- Obesity, Bariatric surgery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux-en-Y gastric bypass surgery or sleeve surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Experimental | Not described Receives: Procedure: Roux-en-Y gastric bypass surgery or sleeve surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Measured: 3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively
Secondary outcomes (14)
Metabolic profile
Insulin, glucose, C-peptide, GIP, glucagon, TSH, thyroid hormones, vitamin D and blood lipids
Measured: 3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively
Physical activity
Measured: 3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively
Appetite sensation
Following a test meal with the use of visual analogue scales (VAS)
Measured: 3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively
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
Measured: 3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively
Mental health
Measured: 3 month preoperatively, 6 month postoperatively and 18 month postoperatively
Social resources
Measured: 3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively
Gut microbiota
Measured: 1 week preoperatively, 6 month postoperatively
Appetite-regulating hormones
GLP-1, PYY, leptin, ghrelin, OXM, CCK, glicentin
Measured: 3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively
Bile acids and fibroblast growth factors
Measured: 3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively
Genetics
Measured: 3 month preoperatively
Body composition
By DXA scans
Measured: 3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively
Cortisol
Measured in hair
Measured: 3 month preoperatively and 18 month postoperatively
Neural activity in reward-processing brain centers
By functional magnetic resonance imaging (fmri)
Measured: preoperatively and 6 month postoperatively
Rewarding value of food
Behavioral test
Measured: preoperatively and 6 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Bariatric Clinic, Department of Surgery, Køge Hospital, Denmark, Copenhagen University Hospital, Hvidovre
- Responsible party
- Principal investigator, Arne Astrup, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070081
- Sponsor's protocol ID
- GO Bypass
- Status last verified
- May 2019
- First submitted
- 18 Feb 2014
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32016415Nielsen 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.
PubMed 31556242Taekker L, Lunn S. The effect of mental health on weight loss after bariatric surgery. Dan Med J. 2019 Feb;66(2):A5532.
PubMed 30722827Sondergaard 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.
PubMed 30421858Christensen 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.
PubMed 30023446Nielsen 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.
PubMed 28411313
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Profiling for Successful Weight Loss After Gastric Bypass or Sleeve Surgery
- ClinicalTrials.gov ID
- NCT02070081
- Acronym / sponsor ID
- GO Bypass
- Conditions
- Obesity
- Keywords
- Obesity, Bariatric surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Bariatric Clinic, Department of Surgery, Køge Hospital, Denmark, Copenhagen University Hospital, Hvidovre
- Study start
- Mar 2014 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 24 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery | Experimental | Procedure: Roux-en-Y gastric bypass surgery or sleeve surgery |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients approved for bariatric surgery at Bariatric Clinic, Køge Hospital, Denmark
Key exclusion criteria (1 listed)
- Inability to comply with the study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roux-en-Y gastric bypass surgery or sleeve surgery | Procedure or surgery | Surgery |
Primary outcome
Weight loss
Time frame: 3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively
14 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2019.
- Derived from this study: PubMed 32016415Nielsen 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.
- Derived from this study: PubMed 31556242Nielsen 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.
- Derived from this study: PubMed 30722827Taekker L, Lunn S. The effect of mental health on weight loss after bariatric surgery. Dan Med J. 2019 Feb;66(2):A5532.
- Derived from this study: PubMed 30421858Sondergaard 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.
- Derived from this study: PubMed 30023446Christensen 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.
- Derived from this study: PubMed 28411313Nielsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Roux-en-Y gastric bypass surgery or sleeve surgery in people with Obesity, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: 3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02070081, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2019.