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DISGAP: Effect of Diet Versus Sleeve Gastrectomy and Gastric Bypass on Appetite

Sponsor
Norwegian University of Science and Technology (Other)
Overall Status
Recruiting
CT.gov ID
NCT04051190
Collaborator
St. Olavs Hospital (Other), Namsos Hospital (Other), University of Copenhagen (Other), University of Leeds (Other), Norwegian University of Life Sciences (Other)
45
Enrollment
2
Locations
3
Arms
39
Anticipated Duration (Months)
22.5
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: VLED group
  • Procedure: Sleeve Gastrectomy group
  • Procedure: Gastric Bypass group
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of Diet-induced Weight Loss Versus Sleeve Gastrectomy and Gastric Bypass on Homeostatic and Hedonic Appetite Markers and Gut Microbiota
Actual Study Start Date :
Sep 2, 2019
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: VLED group

Participants will undergo a 10-week VLED.

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.
Other Names:
  • very-low-energy-diet

    		•
    Experimental: Sleeve Gastrectomy group

    Participants will undergo standard clinical practice prior to surgery.

    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.
    Other Names:
  • very-low-energy-diet

    • 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)
    Experimental: Gatric Bypass group

    Participants will undergo standard clinical practice prior to surgery.

    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.
    Other Names:
  • very-low-energy-diet

    • 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)

    Outcome Measures

    Primary Outcome Measures

    1. Postprandial blood plasma concentration of Glucagon-like peptide-1 (GLP-1, satiety hormone) [Week 11]

      Blood samples will be collected at fasting, and then every 30 minutes after a standardized test meal up to 150 minutes. A radioimmunoassay method will be used to measure the concentration of total GLP-1. This method measures antigen concentrations by the use of antibodies.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Namsos Hospital Namsos Norway
    2 St. Olavs Hospital Trondheim Norway

    Sponsors and Collaborators

    • Norwegian University of Science and Technology
    • St. Olavs Hospital
    • Namsos Hospital
    • University of Copenhagen
    • University of Leeds
    • Norwegian University of Life Sciences

    Investigators

    • Principal Investigator: Catia Martins, PhD, Norwegian University of Science and Technology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Norwegian University of Science and Technology
    ClinicalTrials.gov Identifier:
    NCT04051190
    Other Study ID Numbers:
    • 2019/252
    First Posted:
    Aug 9, 2019
    Last Update Posted:
    Jun 15, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Norwegian University of Science and Technology
    diet
    bariatric surgery
    appetite

    Study Results

    No Results Posted as of Jun 15, 2022