Melanocortin 4 Receptor Mutations and Obesity-associated Diseases

Obesity Clinical Trial

— Mc4Obes  

Official title:

Mutations in the Melanocortin 4 Receptor and Obesity-associated Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01849705
• Other study ID #: B-298
• Secondary ID: H-2-1012-108
• Status: Completed
• Phase: N/A
• First received: May 6, 2013
• Last updated: May 6, 2013
• Start date: October 2012
• Est. completion date: February 2013

Study information

• Verified date: May 2013
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
Denmark	Department of Nutrition, Exercise and Sports, University of Copenhagen	Frederiksberg	Frederiksberg C

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Rhythm Pharmaceuticals, Inc.

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure	Systolic and diastolic blood pressure	Baseline	No
Secondary	Obesity	Obesity measured as BMI	Baseline	No
Secondary	Blood glucose	Blood glucose measured at baseline	Baseline	No
Secondary	MC4R mutations	MC4R mutations detected by sequencing of the coding region of the MC4R gene	Baseline	No