Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-02-21 @ 1:36 AM
Study NCT ID:
NCT00628056
Status:
UNKNOWN
Last Update Posted:
2008-03-04
First Post:
2008-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanisms Responsible for Cardiac and Skeletal Muscle Energetic Impairment in Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058065', 'term': 'Diabetic Cardiomyopathies'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010480', 'term': 'Perhexiline'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-02', 'completionDateStruct': {'date': '2009-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-02-24', 'studyFirstSubmitDate': '2008-02-24', 'studyFirstSubmitQcDate': '2008-02-24', 'lastUpdatePostDateStruct': {'date': '2008-03-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary end point of the Perhexiline intervention study will be the change in cardiac PCr/ATP ratio.', 'timeFrame': '2 Weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Perhexiline', 'diabetes', 'diabetic cardiomyopathy', 'high energy phosphate kinetics', 'magnetic resonance spectroscopy'], 'conditions': ['Diabetic Cardiomyopathy']}, 'descriptionModule': {'briefSummary': 'Diabetes increases the risk of heart failure. This is mainly due to a disease of the blood vessels supplying the heart muscle and/or high blood pressure, but abnormal metabolism may also contribute. We plan to study the mechanisms involved in this abnormal metabolism, whilst also assessing the effects of a drug called Perhexiline which improves the abnormal metabolism that is present in diabetic patients before the development of heart failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetes Mellitus(WHO definition)\n* HbA1C \\<9\n* No history of chest pain\n* No evidence of Coronary Artery Disease or peripheral vascular disease\n* Left ventricular ejection fraction over 50%\n* No evidence of respiratory disease\n\nExclusion Criteria:\n\n* Patients \\< 16years or who cannot provide informed consent\n* Evidence of significant epicardial coronary artery disease\n* Evidence of peripheral vascular disease\n* Abnormal liver function tests\n* Clinically apparent peripheral neuropathy\n* Severe chronic renal failure (creatinine \\>250) or diabetic nephropathy\n* Concomitant use of Amiodarone, Quinidine, Haloperidol or Selective serotonin (5HT) uptake inhibitors such as Fluoxetine and Paroxetine which may inhibit the CYP2D6 enzyme\n* Patients on statin therapy for primary dyslipidemia.\n* Patients with recurrent hypoglycaemia\n* Women of child bearing age who are not using effective contraception (or if pregnancy test positive)'}, 'identificationModule': {'nctId': 'NCT00628056', 'acronym': 'DDCM', 'briefTitle': 'Mechanisms Responsible for Cardiac and Skeletal Muscle Energetic Impairment in Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Birmingham'}, 'officialTitle': 'Mechanisms Responsible for Cardiac and Skeletal Muscle Energetic Impairment in Diabetes', 'orgStudyIdInfo': {'id': 'RRK3159'}, 'secondaryIdInfos': [{'id': 'PG/06/104/21466'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: Perhexiline']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Perhexiline']}], 'interventions': [{'name': 'Perhexiline', 'type': 'DRUG', 'description': 'Intervention with Perhexiline/Placebo at 100mg twice a day for 2 weeks', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B15 2TT', 'city': 'Birmingham', 'state': 'Westmidlands', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Michael Frenneaux, MD FRCP FACC', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Birmingham', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}], 'centralContacts': [{'name': 'Ganesh Nallur Shivu, MBBS MRCP', 'role': 'CONTACT', 'email': 'drgani23@gmail.com', 'phone': '0044 1214145916'}], 'overallOfficials': [{'name': 'Michael Frenneaux, MD FRCP FACC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'British Heart Foundation', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Prof Michael Frenneaux', 'oldOrganization': 'University of Birmingham'}}}}