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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02082496
• Other study ID #: MC4R-2014
• Status: Completed
• Phase: Phase 2
• Start date: June 2014
• Est. completion date: April 2019

Study information

• Verified date: May 2020
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2019
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Liraglutide
S.c. liraglutide 3.0mg once daily

Locations

Country	Name	City	State
Denmark	Department of Biomedical Sciences	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in insulin levels in reponse to GLP-1 RA treatment in obese genetic mutation carriers vs obese controls	pmol/l	4 months intervention