Effect of Diet Versus Sleeve Gastrectomy and Gastric Bypass on Appetite
NCT04051190 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54
Last updated 2023-07-25
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.
Conditions
Interventions
- DIETARY_SUPPLEMENT
-
VLED group
10-week weight loss period with total meal replacement, consisting of 750 kcal/day. Measurements will be taken at baseline (before diet start), 10 weeks after intervention start (Wk11), and at 1 year.
- PROCEDURE
-
Sleeve Gastrectomy group
Standard clinical practice with 2-week diet consisting of 750 kcal/day prior to surgery. The pre- and post-surgical diet of this group will be matched with the VLED group in macro- and micronutrient composition. Measurements will be taken at baseline (before diet start), 10 weeks after intervention start (Wk11), and 1 year after surgery (sleeve gastrectomy)
- PROCEDURE
-
Gastric Bypass group
Standard clinical practice with 2-week diet consisting of 750 kcal/day prior to surgery. The pre- and post-surgical diet of this group will be matched with the VLED group in macro- and micronutrient composition. Measurements will be taken at baseline (before diet start), 10 weeks after intervention start (Wk11), and 1 year after surgery (gastric bypass)
Sponsors & Collaborators
-
St. Olavs Hospital
collaborator OTHER -
Namsos Hospital
collaborator OTHER -
University of Copenhagen
collaborator OTHER -
University of Leeds
collaborator OTHER -
Norwegian University of Life Sciences
collaborator OTHER -
Norwegian University of Science and Technology
lead OTHER
Principal Investigators
-
Catia Martins, PhD · Norwegian University of Science and Technology
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-09-02
- Primary Completion
- 2022-12-31
- Completion
- 2022-12-31
Countries
- Norway
Study Locations
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