Melanocortin 4 Receptor Mutations and Obesity-associated Diseases

NCT ID: NCT01849705

Last Updated: 2013-05-08

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

Total Enrollment

226 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-02-28

Brief Summary

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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

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Conditions

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Obesity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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All subjects

No intervention

No intervention

Intervention Type OTHER

Interventions

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No intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rhythm Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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AAstrup

MD, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arne Astrup, MD, Dr. Med

Role: STUDY_DIRECTOR

Department of Human Nutrition, University of Copenhagen

Lesli H Larsen, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Human Nutrition, University of Copenhagen

Locations

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Department of Nutrition, Exercise and Sports, University of Copenhagen

Frederiksberg, Frederiksberg C, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-2-1012-108

Identifier Type: REGISTRY

Identifier Source: secondary_id

B-298

Identifier Type: -

Identifier Source: org_study_id

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