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Melanocortin 4 Receptor Mutations and Obesity-associated Diseases (Mc4Obes)

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ClinicalTrials.gov Identifier: NCT01849705
Recruitment Status : Completed
First Posted : May 8, 2013
Last Update Posted : May 8, 2013
Sponsor:
Collaborator:
Rhythm Pharmaceuticals, Inc.
Information provided by (Responsible Party):
AAstrup, University of Copenhagen

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.


Condition or disease Intervention/treatment
Obesity Other: No intervention

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Study Type : Observational
Actual Enrollment : 226 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Mutations in the Melanocortin 4 Receptor and Obesity-associated Diseases
Study Start Date : October 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Group/Cohort Intervention/treatment
All subjects
No intervention
Other: No intervention



Primary Outcome Measures :
  1. Blood pressure [ Time Frame: Baseline ]
    Systolic and diastolic blood pressure


Secondary Outcome Measures :
  1. Obesity [ Time Frame: Baseline ]
    Obesity measured as BMI

  2. Blood glucose [ Time Frame: Baseline ]
    Blood glucose measured at baseline

  3. MC4R mutations [ Time Frame: Baseline ]
    MC4R mutations detected by sequencing of the coding region of the MC4R gene


Biospecimen Retention:   Samples With DNA
Whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Men and women aged 18-70 years
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01849705


Locations
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Denmark
Department of Nutrition, Exercise and Sports, University of Copenhagen
Frederiksberg, Frederiksberg C, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
Rhythm Pharmaceuticals, Inc.
Investigators
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Study Director: Arne Astrup, MD, Dr. Med Department of Human Nutrition, University of Copenhagen
Principal Investigator: Lesli H Larsen, PhD Department of Human Nutrition, University of Copenhagen

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Responsible Party: AAstrup, MD, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01849705     History of Changes
Other Study ID Numbers: B-298
H-2-1012-108 ( Registry Identifier: The Danish National Committee on Biomedical Research Ethics )
First Posted: May 8, 2013    Key Record Dates
Last Update Posted: May 8, 2013
Last Verified: May 2013

Keywords provided by AAstrup, University of Copenhagen:
Obesity
MC4R
Blood pressure
Blood glucose

Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms