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

NCT ID: NCT02082496

Last Updated: 2020-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2019-04-30

Brief Summary

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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

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* 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.

Conditions

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Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Control Group

4 months intervention with Liraglutide 3.0 mg daily as subcutanous injection

Group Type EXPERIMENTAL

Liraglutide

Intervention Type DRUG

S.c. liraglutide 3.0mg once daily

Case Group

4 months intervention with Liraglutide 3.0 mg daily as subcutanous injection

Group Type EXPERIMENTAL

Liraglutide

Intervention Type DRUG

S.c. liraglutide 3.0mg once daily

Interventions

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Liraglutide

S.c. liraglutide 3.0mg once daily

Intervention Type DRUG

Other Intervention Names

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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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Eva Pers Winning Iepsen

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jens J Holst, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

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Department of Biomedical Sciences

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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MC4R-2014

Identifier Type: -

Identifier Source: org_study_id

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