ObesityMc4ObesNCT01849705
Melanocortin 4 Receptor Mutations and Obesity-associated Diseases
An observational study of Obesity, run by University of Copenhagen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 226 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2012to Feb 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men and women aged 18-70 years
Who may be able to join
- Age 18-70 years
- Men and women
- BMI > 30 kg/m^2
Who cannot join
- Uncontrolled type 2 diabetes
- Bariatric surgery
- Use of anti-obesity medication
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Nutrition, Exercise and Sports, University of Copenhagen
Frederiksberg, Frederiksberg C, 1958
About this study
Official title: Mutations in the Melanocortin 4 Receptor 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.
- Conditions
- Obesity
- Being tested
- No intervention
- Keywords
- Obesity, MC4R, Blood pressure, Blood glucose
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| All subjects | No intervention Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Systolic and diastolic blood pressure
Measured: Baseline
Secondary outcomes (3)
Obesity
Obesity measured as BMI
Measured: Baseline
Blood glucose
Blood glucose measured at baseline
Measured: Baseline
MC4R mutations
MC4R mutations detected by sequencing of the coding region of the MC4R gene
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2013 (estimated)
- Study startOct 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Rhythm Pharmaceuticals, Inc.
- Responsible party
- Principal investigator, AAstrup, University of Copenhagen
- Investigators
- Arne Astrup, MD, Dr. Med, Study director, Department of Human Nutrition, University of CopenhagenLesli H Larsen, PhD, Principal investigator, Department of Human Nutrition, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01849705
- Sponsor's protocol ID
- B-298
- Other IDs
- H-2-1012-108
- Acronym
- Mc4Obes
- Status last verified
- May 2013
- First submitted
- 6 May 2013
- Last updated
- 8 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mutations in the Melanocortin 4 Receptor and Obesity-associated Diseases
- ClinicalTrials.gov ID
- NCT01849705
- Acronym / sponsor ID
- Mc4Obes / B-298
- Conditions
- Obesity
- Keywords
- Obesity, MC4R, Blood pressure, Blood glucose
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Rhythm Pharmaceuticals, Inc.
- Study start
- Oct 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 8 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | – | Other: No interventionNo intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women aged 18-70 years
Key inclusion criteria (3 listed)
- Age 18-70 years
- Men and women
- BMI > 30 kg/m^2
Key exclusion criteria (3 listed)
- Uncontrolled type 2 diabetes
- Bariatric surgery
- Use of anti-obesity medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Other | All subjects |
Primary outcome
Blood pressure
Time frame: Baseline
Systolic and diastolic blood pressure
3 secondary outcomes
Obesity
Time frame: Baseline
Blood glucose
Time frame: Baseline
MC4R mutations
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arne Astrup, MD, Dr. Med study director
Department of Human Nutrition, University of Copenhagen
Lesli H Larsen, PhD principal investigator
Department of Human Nutrition, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2013.