NCT04051190

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2019

Completed
24 days until next milestone

Study Start

First participant enrolled

September 2, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

3.3 years

First QC Date

August 7, 2019

Last Update Submit

July 24, 2023

Conditions

Obesity

Keywords

dietbariatric surgeryappetite

Outcome Measures

Primary Outcomes (1)

  • Postprandial blood plasma concentration of Glucagon-like peptide-1 (GLP-1, satiety hormone)

    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.

    Week 11

Study Arms (3)

VLED group

EXPERIMENTAL

Participants will undergo a 10-week VLED.

Dietary Supplement: VLED group

Sleeve Gastrectomy group

EXPERIMENTAL

Participants will undergo standard clinical practice prior to surgery.

Dietary Supplement: VLED groupProcedure: Sleeve Gastrectomy group

Gatric Bypass group

EXPERIMENTAL

Participants will undergo standard clinical practice prior to surgery.

Dietary Supplement: VLED groupProcedure: Gastric Bypass group

Interventions

VLED groupDIETARY_SUPPLEMENT

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.

Also known as: very-low-energy-diet
Gatric Bypass groupSleeve Gastrectomy groupVLED group
Sleeve Gastrectomy groupPROCEDURE

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)

Sleeve Gastrectomy group
Gastric Bypass groupPROCEDURE

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)

Gatric Bypass group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Namsos Hospital

Namsos, Norway

Location

St. Olavs Hospital

Trondheim, Norway

Location

Related Publications (6)

  • Finn A, Cedillo Y, Aukan M, Gower B, Martins C. Glucose-Dependent Insulinotropic Polypeptide and Glucagon After Weight Loss Induced by Diet or Bariatric Surgery. Obesity (Silver Spring). 2025 Dec;33(12):2277-2288. doi: 10.1002/oby.70049. Epub 2025 Sep 29.

    PMID: 41024443DERIVED

  • Aukan MI, Rehfeld JF, Holst JJ, Martins C. Plasma concentration of gastrointestinal hormones and subjective appetite ratings after diet or bariatric surgery: 1-year results from the DISGAP study. Int J Obes (Lond). 2025 Feb;49(2):306-314. doi: 10.1038/s41366-024-01658-5. Epub 2024 Nov 21.

    PMID: 39572763DERIVED

  • Martins C, Aukan MI, De Luca M. Lower levels of plasma syndecan-4 are associated with loss of body weight and fat-free mass after bariatric surgery. BMC Res Notes. 2024 Jun 15;17(1):164. doi: 10.1186/s13104-024-06822-8.

    PMID: 38879520DERIVED

  • Martins C, Nymo S, Aukan MI, Roekenes JA, Coutinho SR, Hunter GR, Gower BA. Association between ss-Hydroxybutyrate Plasma Concentrations after Hypocaloric Ketogenic Diets and Changes in Body Composition. J Nutr. 2023 Jul;153(7):1944-1949. doi: 10.1016/j.tjnut.2023.05.010. Epub 2023 May 12.

    PMID: 37182692DERIVED

  • 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.

    PMID: 36046953DERIVED

  • 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.

    PMID: 35393266DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Catia Martins, PhD

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2019

First Posted

August 9, 2019

Study Start

September 2, 2019

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

July 25, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

NO(2)