Clinical trial NCT02070081: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Bariatric surgery
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Bariatric Clinic, Department of Surgery, Køge Hospital, Denmark
name: The Danish Research Centre for Magnetic Resonance, Hvidovre Hospital, Denmark
First posted: 2014-02-24
Enrollment: 55
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Weight loss
timeFrame: 3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively
Secondary outcomes:
measure: Metabolic profile
timeFrame: 3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively
measure: Physical activity
timeFrame: 3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively
measure: Appetite sensation
timeFrame: 3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively
measure: Taste preferences and taste perception
timeFrame: 3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively
measure: Mental health
timeFrame: 3 month preoperatively, 6 month postoperatively and 18 month postoperatively
measure: Social resources
timeFrame: 3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively
measure: Gut microbiota
timeFrame: 1 week preoperatively, 6 month postoperatively
measure: Appetite-regulating hormones
timeFrame: 3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively
measure: Bile acids and fibroblast growth factors
timeFrame: 3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively
measure: Genetics
timeFrame: 3 month preoperatively
measure: Body composition
timeFrame: 3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively
measure: Cortisol
timeFrame: 3 month preoperatively and 18 month postoperatively
measure: Neural activity in reward-processing brain centers
timeFrame: preoperatively and 6 month postoperatively
measure: Rewarding value of food
timeFrame: preoperatively and 6 month postoperatively
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Faculty of Science, NEXS
Study officials:
References:
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.
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.
citation: Taekker L, Lunn S. The effect of mental health on weight loss after bariatric surgery. Dan Med J. 2019 Feb;66(2):A5532.
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.
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.
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.