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

May 12, 2020 updated by: Eva Pers Winning Iepsen, University of Copenhagen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2200
        • Department of Biomedical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

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
Time Frame: 4 months intervention
pmol/l
4 months intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Investigators

  • Principal Investigator: Jens J Holst, Professor, University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

March 6, 2014

First Submitted That Met QC Criteria

March 7, 2014

First Posted (Estimate)

March 10, 2014

Study Record Updates

Last Update Posted (Actual)

May 13, 2020

Last Update Submitted That Met QC Criteria

May 12, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MC4R-2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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