Effect of Diet Versus Sleeve Gastrectomy and Gastric Bypass on Appetite

Obesity Clinical Trial

— DISGAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04051190
• Other study ID #: 2019/252
• Status: Completed
• Phase: N/A
• Start date: September 2, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2023
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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)
• 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)

Locations

Country	Name	City	State
Norway	Namsos Hospital	Namsos
Norway	St. Olavs Hospital	Trondheim

Sponsors (6)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Namsos Hospital, Norwegian University of Life Sciences, St. Olavs Hospital, University of Copenhagen, University of Leeds

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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