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OpenTrials
Completed

NCT Number: NCT01849705

Melanocortin 4 Receptor Mutations and Obesity-associated Diseases

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Nutrition, Exercise and Sports, University of Copenhagen

Frederiksberg, Frederiksberg C, 1958, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

Primary outcomes

  1. Blood pressure

    Time frame: Baseline

    Systolic and diastolic blood pressure

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Rhythm Pharmaceuticals, Inc.

Registry information

Official study title

Mutations in the Melanocortin 4 Receptor and Obesity-associated Diseases

Acronym: Mc4Obes

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 8, 2013
Registry last updated
May 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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