Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-29 @ 12:15 PM
Study NCT ID:
NCT00192803
Status:
UNKNOWN
Last Update Posted:
2006-02-23
First Post:
2005-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-Insulin Dependent Diabetes Mellitus (NIDDM) and Angiotensin Converting Enzyme 2 (ACE2): Diabetic Patients Treated With Antihypertensive Drugs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C081643', 'term': 'candesartan'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'ECT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'lastUpdateSubmitDate': '2006-02-22', 'studyFirstSubmitDate': '2005-09-14', 'studyFirstSubmitQcDate': '2005-09-14', 'lastUpdatePostDateStruct': {'date': '2006-02-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ACE and ACE2 activities in monocytes'}]}, 'conditionsModule': {'keywords': ['niddm', 'ace2', 'NIDDM patients'], 'conditions': ['NIDDM']}, 'descriptionModule': {'briefSummary': 'This feasibility study is designed to examine modulation of the relative activities of ACE and ACE2 in diabetic patients following treatment with the angiotensin type 1 receptor (AT1R) antagonist, Candesartan.\n\nThis study will provide a closer insight to the possible involvement of the renin-angiotensin system (RAS)-related enzymatic components in development or attenuation of vascular pathogenesis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Non-smokers\n* Type II DM diagnosed patients\n* Blood pressure \\< 135/90\n* Serum HbA1C \\> 7%\n* Serum creatinine \\< 1mg%\n* Urine microalbumin \\< 300 mg/day\n* Body mass index (BMI) \\< 35 kg/m2\n\nExclusion Criteria:\n\n* Insulin-dependent diabetic patients\n* Patient with persistent microalbuminuria\n* Patient with history of severe hypertension\n* Congestive heart failure\n* Patient receiving renin-angiotensin-aldosterone system (RAAS)-related anti-hypertensive medications.\n* Patient with major hepatic disease'}, 'identificationModule': {'nctId': 'NCT00192803', 'briefTitle': 'Non-Insulin Dependent Diabetes Mellitus (NIDDM) and Angiotensin Converting Enzyme 2 (ACE2): Diabetic Patients Treated With Antihypertensive Drugs', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'ACE/ACE2 Ratio in Diabetic Patients Treated With Antihypertensive Drugs', 'orgStudyIdInfo': {'id': 'ACE2.CTIL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'candesartan', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'country': 'Israel', 'contacts': [{'name': 'Ayelet Raz, MD', 'role': 'CONTACT', 'phone': '972-4-8543072'}, {'name': 'Ayelet Raz, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Internal Ward "A", Rambam Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Shlomo Keidar, MD', 'role': 'CONTACT', 'email': 'skeidar@rambam.health.gov.il', 'phone': '97248542518'}], 'overallOfficials': [{'name': 'Shlomo Keidar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}}}}