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

NCT02082496 | Completed Phase 2 DMC

• 1 other identifier: MC4R-2014
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity; Obesity Genetics; GLP-1; GLP-1 Receptor Agonists

Outcome Measures

Primary Outcomes (1)

• Difference in insulin levels in reponse to GLP-1 RA treatment in obese genetic mutation carriers vs obese controls

  pmol/l

  4 months intervention

Study Arms (2)

Control Group

EXPERIMENTAL

4 months intervention with Liraglutide 3.0 mg daily as subcutanous injection

Drug: Liraglutide

Case Group

EXPERIMENTAL

4 months intervention with Liraglutide 3.0 mg daily as subcutanous injection

Drug: Liraglutide

Interventions

Liraglutide DRUG

S.c. liraglutide 3.0mg once daily

Also known as: 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

Case Group; Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI above 28 (kg/m2)
• age 18-65 years
• otherwise healthy

You may not qualify if:

• pregnancy or breastfeeding
• Type 2 Diabetes
• suffering from severe medical conditions
• Recruitment for this study finished November 2015

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

Department of Biomedical Sciences

Copenhagen, 2200, Denmark

Location

MeSH Terms

Conditions

Obesity

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Jens J Holst, Professor

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: March 6, 2014
• First Posted: March 10, 2014
• Study Start: June 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2019
• Last Updated: May 13, 2020

Record last verified: 2020-05

Locations

DK (1)