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

Study Overview
=================
Brief 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.

Detailed 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.

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

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: Liraglutide


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control Group<br>4 months intervention with Liraglutide 3.0 mg daily as subcutanous injection | Drug: Liraglutide<br>* S.c. liraglutide 3.0mg once daily<br>* Other names: US Class Codes: 006, 018, 044, 046, 051, 052;|
| Experimental: Case Group<br>4 months intervention with Liraglutide 3.0 mg daily as subcutanous injection | Drug: Liraglutide<br>* S.c. liraglutide 3.0mg once daily<br>* Other names: US Class Codes: 006, 018, 044, 046, 051, 052;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in insulin levels in reponse to GLP-1 RA treatment in obese genetic mutation carriers vs obese controls | pmol/l | 4 months intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Obesity Genetics, GLP-1, GLP-1 Receptor Agonists