Overview

This trial is active, not recruiting.

Condition obesity
Treatment liraglutide
Phase phase 2
Sponsor University of Copenhagen
Start date June 2014
End date April 2016
Trial size 50 participants
Trial identifier NCT02082496, MC4R-2014

Summary

The obesity epidemic is attributable to dietary and behavioral trends acting on a person's genetic makeup to determine body mass and susceptibility to obesity-related diseases. Common forms of obesity have a strong hereditary component and many genetic pathways that contribute to obesity have already ben identified.

Glucagon-like peptide (GLP) -1 is an incretin hormone that potentiates glucose-stimulated insulin secretion. However, GLP-1 also acts as an appetite-inhibiting hormone affecting the appetite center in the hypothalamus. Today, GLP-1 agonists are available for treatment of type 2 diabetes, and their treatment potential in obesity is an area of active research.

The aim of this study is to explore if the appetite inhibiting effect of GLP-1 is intact in people diagnosed with obesity causing genetic disorders and to investigate the physiological role of GLP-1 on food intake and appetite regulation in this group.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
4 months intervention with Liraglutide 3.0 mg daily as subcutanous injection
liraglutide Victoza, Novo Nordisk A/S in DK-2880 Bagsvaerd
S.c. liraglutide 3.0mg once daily
(Experimental)
4 months intervention with Liraglutide 3.0 mg daily as subcutanous injection
liraglutide Victoza, Novo Nordisk A/S in DK-2880 Bagsvaerd
S.c. liraglutide 3.0mg once daily

Primary Outcomes

Measure
Difference in leptin levels in reponse to GLP-1 RA treatment in obese genetic mutation carriers vs obese controls
time frame: 4 months intervention

Secondary Outcomes

Measure
Difference in insulin levels in reponse to GLP-1 RA treatment in obese genetic mutation carriers vs obese controls
time frame: 4 months intervention

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - BMI above 28 (kg/m2) - age 18-65 years - otherwise healthy Exclusion Criteria: - pregnancy or breastfeeding - Type 2 Diabetes - suffering from severe medical conditions Recruitment for this study finished November 2015

Additional Information

Official title Exploration of the Physiological Effect of GLP-1 in Obese Adults Diagnosed With Obesity Causing Genetic Mutations
Principal investigator Jens J Holst, Professor
Description - Exploration of the physiological role of GLP-1 concerning food intake and appetite regulation in obese adults diagnosed with obesity related genetic disorders. - Assessment of the effect of GLP-1 on body composition, bone mineral density, energy expenditure, cardiac function, glucose tolerance, insulin sensitivity, lipid concentrations and neuroendocrine function. - Assessment of the impact of the leptin induced adaptive thermogenesis response in the weight reduced study participants. - Investigating the alteration of the composition of gut bacteria as well as subjective ratings of satiety and hunger before after supplement with GLP-1.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Copenhagen.