Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2026-03-13 @ 4:12 AM
Study NCT ID:
NCT03917212
Status:
COMPLETED
Last Update Posted:
2019-04-16
First Post:
2019-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Energy Metabolism in Branched-chain Organic Acidemias
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-15', 'studyFirstSubmitDate': '2019-04-09', 'studyFirstSubmitQcDate': '2019-04-15', 'lastUpdatePostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hepatic and skeletal muscle energy metabolism', 'timeFrame': 'At baseline', 'description': 'Hepatic and skeletal muscle energy metabolism assessed by magnetic resonance spectroscopy'}], 'secondaryOutcomes': [{'measure': 'Insulin sensitivity', 'timeFrame': 'At baseline', 'description': 'Insulin sensitivity measured from oral glucose tolerance test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Organic acidemias', 'Mitochondria', 'Oxidative stress', 'Fatty liver', 'Dyslipidemia'], 'conditions': ['Energy Metabolism', 'Metabolic Syndrome', 'Insulin Resistance']}, 'descriptionModule': {'briefSummary': 'Energy metabolism and insulin sensitivity were assessed in a case-control study in patients with branched-chain organic acidemias.', 'detailedDescription': 'Children and adults with branched-chain organic acidemias and matched healthy humans underwent deep metabolic phenotyping using non-invasive magnetic resonance spectroscopy, oral glucose tolerance tests and measurements of leucocyte respirometry in order to assess changes in energy metabolism and insulin sensitivity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with known propionic acidemia, methylmalonic acidemia or isovaleric acidemia were enrolled as well as healthy humans of comparable age, sex and BMI', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* known branched-chain organic acidemia diagnosed by enzymatic or genetic test\n* age\\>5 years\n\nExclusion Criteria:\n\n* acute inflammatory conditions with fever, cold symptoms, gastro-intestinal infection within the last 24 hours\n* contraindications for an oral glucose tolerance test such as fasting blood glucose \\>126 mg/dl, severe chronic gastrointestinal conditions, allergy against black currant\n* contraindications for magnetic resonance tomography (MRT) such as claustrophobia, metallic implants which are not MRT compatible'}, 'identificationModule': {'nctId': 'NCT03917212', 'briefTitle': 'Energy Metabolism in Branched-chain Organic Acidemias', 'organization': {'class': 'OTHER', 'fullName': 'German Diabetes Center'}, 'officialTitle': 'Non-invasive Measurement of Energy Metabolism in Patients With Primary and Secondary Mitochondrial Diseases', 'orgStudyIdInfo': {'id': 'MITO-MRS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Patients with propionic acidemia, isovaleric acidemia, methylmalonic acidemia', 'interventionNames': ['Other: No intervention']}, {'label': 'Controls', 'description': 'Healthy humans', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention, observational study with metabolic characterisation', 'armGroupLabels': ['Controls', 'Patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Düsseldorf', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': "Department of General Pediatrics, Neonatology and Pediatric Cardiology of the University Children's Hospital Düsseldorf", 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Düsseldorf', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Institute for Clinical Diabetology, German Diabetes Center', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'overallOfficials': [{'name': 'Michael Roden, Professeor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'German Diabetes Center'}, {'name': 'Regina Ensenauer, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Düsseldorf"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'German Diabetes Center', 'class': 'OTHER'}, 'collaborators': [{'name': "University Children's Hospital, Düsseldorf", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}