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

University of Copenhagen

Status and phase: Completed; Phase 2

Conditions: Obesity

Treatments: Drug: Liraglutide

Study type: Interventional

Funder types: Other

Identifiers

NCT02082496

MC4R-2014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Control Group

Experimental group

Description:

4 months intervention with Liraglutide 3.0 mg daily as subcutanous injection

Treatment:

Drug: Liraglutide

Case Group

Experimental group

Description:

4 months intervention with Liraglutide 3.0 mg daily as subcutanous injection

Treatment:

Drug: Liraglutide