Melanocortin 4 Receptor Mutations and Obesity-associated... | NCT01849705

Studies
Melanocortin 4 Receptor Mutations and Obesity-associated Diseases

NCT01849705

Sponsor

University of Copenhagen

Status

Completed

Last Update Posted

May 8, 2013Estimated

Enrollment

226Actual

Phase

Not provided

Conditions

Obesity

Interventions

No intervention

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

ID	Type	Description	Link
H-2-1012-108	Registry Identifier	The Danish National Committee on Biomedical Research Ethics

Status Module

Record Verification Date

May 2013

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

Oct 2012

Primary Completion Date

Feb 2013Actual

Completion Date

Feb 2013Actual

First Submitted Date

May 6, 2013

First Submission Date that Met QC Criteria

May 6, 2013

First Posted Date

May 8, 2013Estimated

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 6, 2013

Last Update Posted Date

May 8, 2013Estimated

Name	Class
Rhythm Pharmaceuticals, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

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

Mutations in the melanocortin 4 receptor (MC4R) are the most common form of monogenic obesity, and can explain 2-6% of severe obesity.

Studies have shown that mutations in MC4R are associated with increased fat mass, height-for-age, appetite and insulin resistance among children. In adults, mutations in MC4R are less penetrant for these phenotypes but it has been observed that individuals with MC4R mutations have a smaller than expected blood pressure for their degree of obesity.

The purpose of this study is to explore the association between functional MC4R mutations and obesity, insulin resistance and blood pressure.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

226Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
All subjects		No intervention	Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other		All subjects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood pressure	Systolic and diastolic blood pressure	Baseline

Secondary Outcomes

Measure	Description	Time Frame
Obesity	Obesity measured as BMI	Baseline
Blood glucose	Blood glucose measured at baseline	Baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-70 years
Men and women
BMI > 30 kg/m^2

Exclusion Criteria:

Uncontrolled type 2 diabetes
Bariatric surgery
Use of anti-obesity medication

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Men and women aged 18-70 years

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arne Astrup, MD, Dr. Med	Department of Human Nutrition, University of Copenhagen	Study Director
Lesli H Larsen, PhD	Department of Human Nutrition, University of Copenhagen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Nutrition, Exercise and Sports, University of Copenhagen		Frederiksberg	Frederiksberg C	1958	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