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

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ClinicalTrials.gov Identifier: NCT02082496
Recruitment Status : Completed
First Posted : March 10, 2014
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Eva Pers Winning Iepsen, 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.


Condition or disease Intervention/treatment Phase
Obesity Drug: Liraglutide Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Exploration of the Physiological Effect of GLP-1 in Obese Adults Diagnosed With Obesity Causing Genetic Mutations
Actual Study Start Date : June 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arm Intervention/treatment
Experimental: Control Group
4 months intervention with Liraglutide 3.0 mg daily as subcutanous injection
Drug: Liraglutide
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

Experimental: Case Group
4 months intervention with Liraglutide 3.0 mg daily as subcutanous injection
Drug: Liraglutide
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 Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082496


Locations
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Denmark
Department of Biomedical Sciences
Copenhagen, Denmark, 2200
Sponsors and Collaborators
University of Copenhagen
Investigators
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Principal Investigator: Jens J Holst, Professor University of Copenhagen
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Responsible Party: Eva Pers Winning Iepsen, M.D., University of Copenhagen
ClinicalTrials.gov Identifier: NCT02082496    
Other Study ID Numbers: MC4R-2014
First Posted: March 10, 2014    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
Keywords provided by Eva Pers Winning Iepsen, University of Copenhagen:
Obesity
Obesity Genetics
GLP-1
GLP-1 Receptor Agonists
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists