Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-16 @ 9:17 PM
Study NCT ID:
NCT01849705
Status:
COMPLETED
Last Update Posted:
2013-05-08
First Post:
2013-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Melanocortin 4 Receptor Mutations and Obesity-associated Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 226}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-06', 'studyFirstSubmitDate': '2013-05-06', 'studyFirstSubmitQcDate': '2013-05-06', 'lastUpdatePostDateStruct': {'date': '2013-05-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': 'Baseline', 'description': 'Systolic and diastolic blood pressure'}], 'secondaryOutcomes': [{'measure': 'Obesity', 'timeFrame': 'Baseline', 'description': 'Obesity measured as BMI'}, {'measure': 'Blood glucose', 'timeFrame': 'Baseline', 'description': 'Blood glucose measured at baseline'}, {'measure': 'MC4R mutations', 'timeFrame': 'Baseline', 'description': 'MC4R mutations detected by sequencing of the coding region of the MC4R gene'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obesity', 'MC4R', 'Blood pressure', 'Blood glucose'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'Mutations in the melanocortin 4 receptor (MC4R) are the most common form of monogenic obesity, and can explain 2-6% of severe obesity.\n\nStudies 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.\n\nThe purpose of this study is to explore the association between functional MC4R mutations and obesity, insulin resistance and blood pressure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men and women aged 18-70 years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-70 years\n* Men and women\n* BMI \\> 30 kg/m\\^2\n\nExclusion Criteria:\n\n* Uncontrolled type 2 diabetes\n* Bariatric surgery\n* Use of anti-obesity medication'}, 'identificationModule': {'nctId': 'NCT01849705', 'acronym': 'Mc4Obes', 'briefTitle': 'Melanocortin 4 Receptor Mutations and Obesity-associated Diseases', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Mutations in the Melanocortin 4 Receptor and Obesity-associated Diseases', 'orgStudyIdInfo': {'id': 'B-298'}, 'secondaryIdInfos': [{'id': 'H-2-1012-108', 'type': 'REGISTRY', 'domain': 'The Danish National Committee on Biomedical Research Ethics'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'All subjects', 'description': 'No intervention', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'armGroupLabels': ['All subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1958', 'city': 'Frederiksberg', 'state': 'Frederiksberg C', 'country': 'Denmark', 'facility': 'Department of Nutrition, Exercise and Sports, University of Copenhagen', 'geoPoint': {'lat': 55.67938, 'lon': 12.53463}}], 'overallOfficials': [{'name': 'Arne Astrup, MD, Dr. Med', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Human Nutrition, University of Copenhagen'}, {'name': 'Lesli H Larsen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Human Nutrition, University of Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rhythm Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Professor', 'investigatorFullName': 'AAstrup', 'investigatorAffiliation': 'University of Copenhagen'}}}}