GLP-1 Response and Effect in Individuals With Obesity Causing Genetic Mutations

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. Furthermore, common forms of obesity have a strong hereditary component and many genetic pathways that contribute to obesity have already ben identified.

Glucagon-like peptide-1 (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 receptor agonists are available for the 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Biomedical Sciences

Copenhagen, 2200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

liraglutide

Drug

S.c. liraglutide 3.0mg once daily

Other names: Victoza, Novo Nordisk A/S in DK-2880 Bagsvaerd, Serial number:76477425, International code name: 005, US Class Codes: 006, 018, 044, 046, 051, 052

Primary outcomes

Difference in insulin levels in reponse to GLP-1 RA treatment in obese genetic mutation carriers vs obese controls

Time frame: 4 months intervention

pmol/l

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Official study title

Exploration of the Physiological Effect of GLP-1 in Obese Adults Diagnosed With Obesity Causing Genetic Mutations

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2019
First posted: Mar 10, 2014
Registry last updated: May 13, 2020

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.

Published trials that share one or more normalized conditions with this study.

Completed