NCT01849705

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
226

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2013

Completed
Last Updated

May 8, 2013

Status Verified

May 1, 2013

Enrollment Period

4 months

First QC Date

May 6, 2013

Last Update Submit

May 6, 2013

Conditions

Obesity

Keywords

ObesityMC4RBlood pressureBlood glucose

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

    Systolic and diastolic blood pressure

    Baseline

Secondary Outcomes (3)

  • Obesity

    Baseline

  • Blood glucose

    Baseline

  • MC4R mutations

    Baseline

Study Arms (1)

All subjects

No intervention

Other: No intervention

Interventions

No interventionOTHER
All subjects

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men and women aged 18-70 years

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nutrition, Exercise and Sports, University of Copenhagen

Frederiksberg, Frederiksberg C, 1958, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Professor

Study Record Dates

First Submitted

May 6, 2013

First Posted

May 8, 2013

Study Start

October 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

May 8, 2013

Record last verified: 2013-05

Locations

DK(1)