Effect of Diet Versus Sleeve Gastrectomy and Gastric Bypass on Appetite

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: VLED group; Procedure: Gastric Bypass group; Procedure: Sleeve Gastrectomy group

• Registration Number: NCT04051190
• Lead Sponsor: Norwegian University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-07
• Study First Submitted QC: 2019-08-08
• Study First Posted: 2019-08-09
• Study Start: 2019-09-02
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-24
• Last Update Posted: 2023-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleeve Gastrectomy group	VLED group	Participants will undergo standard clinical practice prior to surgery.
Gatric Bypass group	Gastric Bypass group	Participants will undergo standard clinical practice prior to surgery.
VLED group	VLED group	Participants will undergo a 10-week VLED.
Sleeve Gastrectomy group	Sleeve Gastrectomy group	Participants will undergo standard clinical practice prior to surgery.
Gatric Bypass group	VLED group	Participants will undergo standard clinical practice prior to surgery.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Namsos Hospital; 🇳🇴 Namsos, Norway

St. Olavs Hospital; 🇳🇴 Trondheim, Norway