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

Phase 2
Completed
Conditions
Obesity
Interventions
Registration Number
NCT02082496
Lead Sponsor
University of Copenhagen
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
50
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Case GroupLiraglutide4 months intervention with Liraglutide 3.0 mg daily as subcutanous injection
Control GroupLiraglutide4 months intervention with Liraglutide 3.0 mg daily as subcutanous injection
Primary Outcome Measures
NameTimeMethod
Difference in insulin levels in reponse to GLP-1 RA treatment in obese genetic mutation carriers vs obese controls4 months intervention

pmol/l

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Department of Biomedical Sciences

🇩🇰

Copenhagen, Denmark

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