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Completed

NCT Number: NCT04051190

Effect of Diet Versus Sleeve Gastrectomy and Gastric Bypass on Appetite

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Namsos Hospital, Namsos, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VLED group

Dietary 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.

Other names: very-low-energy-diet

Sleeve Gastrectomy group

Procedure

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)

Gastric Bypass group

Procedure

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)

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

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

Registry information

Official study title

Effects of Diet-induced Weight Loss Versus Sleeve Gastrectomy and Gastric Bypass on Homeostatic and Hedonic Appetite Markers and Gut Microbiota

Acronym: DISGAP

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 9, 2019
Registry last updated
Jul 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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