GLP-1 Response and Effect in Individuals With Obesity Cau... | NCT02082496

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

NCT02082496

Sponsor

University of Copenhagen

Status

Completed

Last Update Posted

May 13, 2020Actual

Enrollment

50Actual

Phase

Phase 2

Conditions

Obesity

Interventions

Liraglutide

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014Actual

Primary Completion Date

Apr 2016Actual

Completion Date

Apr 2019Actual

First Submitted Date

Mar 6, 2014

First Submission Date that Met QC Criteria

Mar 7, 2014

First Posted Date

Mar 10, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2020

Last Update Posted Date

May 13, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eva Pers Winning Iepsen, M.D., University of CopenhagenPrincipal Investigator

Lead Sponsor

University of CopenhagenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Liraglutide	Drug	S.c. liraglutide 3.0mg once daily	Case Group Control Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference in insulin levels in reponse to GLP-1 RA treatment in obese genetic mutation carriers vs obese controls	pmol/l	4 months intervention

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jens J Holst, Professor	University of Copenhagen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Biomedical Sciences		Copenhagen		2200	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069450	Liraglutide

Ancestor Terms

ID	Term
D052216	Glucagon-Like Peptide 1
D004763	Glucagon-Like Peptides
D052336	Proglucagon
D005768	Gastrointestinal Hormones

Browse Leaves

Not provided

Browse Branches

Not provided