Clinical trial NCT04051190: Effect of Diet Versus Sleeve Gastrectomy and Gastric Bypass on Appetite
Official title: Effects of Diet-induced Weight Loss Versus Sleeve Gastrectomy and Gastric Bypass on Homeostatic and Hedonic Appetite Markers and Gut Microbiota
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: diet
bariatric surgery
appetite
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Namsos Hospital
name: University of Copenhagen
name: University of Leeds
name: Norwegian University of Life Sciences
First posted: 2019-08-09
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The biggest challenge in obesity management is maintaining weight loss in the long-term. Currently, bariatric surgery is the most effective treatment, leading to sustained weight loss that is not yet achievable with lifestyle intervention (e.g. diet). The reasons behind its success is still not clearly understood, but beneficial changes in the homeostatic and hedonic appetite systems (the two major physiological regulators of appetite), along with the microbiome (known to have a mediatory effect on appetite) have been shown to occur after bariatric surgery. These alterations are in opposition to what is seen after diet-induced weight loss. Today, the component of appetite regulation that drives bariatric surgeys' long-term success is still unknown. By comparing a lifestyle and surgical intervention in parallel, the investigators can observe the impact of a similar magnitude of weight loss on these three domains of appetite regulation simultaneously, thereby illuminating the mechanisms behind bariatric surgerys' success.


Eligibility criteria: Inclusion Criteria:

* scheduled for bariatric surgery
* patient in obesity clinic
* Body mass index (BMI) 35-55

Exclusion Criteria:

* Currently taking medication known to affect energy metabolism or appetite
* Current cancer diagnosis
* Substance abuse
* Enrolled in another obesity treatment
* Eating disorders
* pre-existing endocrine disorders (e.g. diabetes) will not be excluded, but final analysis will controlled for these conditions

Primary outcomes:
measure: Postprandial blood plasma concentration of Glucagon-like peptide-1 (GLP-1, satiety hormone)
timeFrame: Week 11
Secondary outcomes:
Other outcomes:
Locations:
city: Namsos
country: Norway
facility: Namsos Hospital
city: Trondheim
country: Norway
facility: St. Olavs Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Catia Martins, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aukan MI, Brandsaeter IO, Skarvold S, Finlayson G, Nymo S, Coutinho S, Martins C. Changes in hedonic hunger and food reward after a similar weight loss induced by a very low-energy diet or bariatric surgery. Obesity (Silver Spring). 2022 Oct;30(10):1963-1972. doi: 10.1002/oby.23535. Epub 2022 Aug 31.
citation: Nymo S, Lundanes J, Aukan M, Sandvik J, Johnsen G, Graeslie H, Larsson I, Martins C. Diet and physical activity are associated with suboptimal weight loss and weight regain 10-15 years after Roux-en-Y gastric bypass: A cross-sectional study. Obes Res Clin Pract. 2022 Mar-Apr;16(2):163-169. doi: 10.1016/j.orcp.2022.03.006. Epub 2022 Apr 4.