Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-29 @ 2:04 PM
Study NCT ID:
NCT00905528
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2009-05-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TRENDY Follow-up: Study on Endothelial Function in Subjects With Type 2 Diabetes Mellitus
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': 'D000077333', 'term': 'Telmisartan'}, {'id': 'D017257', 'term': 'Ramipril'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-24', 'studyFirstSubmitDate': '2009-05-19', 'studyFirstSubmitQcDate': '2009-05-19', 'lastUpdatePostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in eGFR after 1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['type 2 diabetes mellitus', 'endothelial function', 'renal hemodynamics'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '18622262', 'type': 'BACKGROUND', 'citation': 'Ritt M, Ott C, Delles C, Schneider MP, Schmieder RE. Impact of the endothelial nitric oxide synthase gene G894T polymorphism on renal endothelial function in patients with type 2 diabetes. Pharmacogenet Genomics. 2008 Aug;18(8):699-707. doi: 10.1097/FPC.0b013e32830500b1.'}, {'pmid': '19100670', 'type': 'RESULT', 'citation': 'Ritt M, Ott C, Raff U, Schneider MP, Schuster I, Hilgers KF, Schlaich MP, Schmieder RE. Renal vascular endothelial function in hypertensive patients with type 2 diabetes mellitus. Am J Kidney Dis. 2009 Feb;53(2):281-9. doi: 10.1053/j.ajkd.2008.10.041. Epub 2008 Dec 19.'}, {'pmid': '38682786', 'type': 'DERIVED', 'citation': 'Natale P, Palmer SC, Navaneethan SD, Craig JC, Strippoli GF. Angiotensin-converting-enzyme inhibitors and angiotensin receptor blockers for preventing the progression of diabetic kidney disease. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD006257. doi: 10.1002/14651858.CD006257.pub2.'}]}, 'descriptionModule': {'briefSummary': 'Basal nitric oxide (NO) activity plays a pivotal role in the regulation of glomerular hemodynamics, and in animal experiments its alteration has been associated with morphological changes characteristic of diabetic nephropathy. The investigators aimed to assess in a prospective study: 1. basal NO activity of renal vasculature and 2. renal hemodynamics to examine whether impairment of basal NO activity of the renal vasculature is related to development and progression of diabetic nephropathy and other cardiovascular endpoints.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with type 2 diabetes mellitus and normo or microalbuminuria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 Diabetes mellitus\n\nExclusion Criteria:\n\n* Macroalbuminuria\n* Symptomatic cardiovascular disease'}, 'identificationModule': {'nctId': 'NCT00905528', 'briefTitle': 'TRENDY Follow-up: Study on Endothelial Function in Subjects With Type 2 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'University of Erlangen-Nürnberg Medical School'}, 'officialTitle': 'Prospective Study on Endothelial Function in Subjects With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'Re.-No. 3204'}, 'secondaryIdInfos': [{'id': 'SFB TP B5'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'description': 'Subjects with type 2 diabetes mellitus, eGFR \\> 80, hypertension, no overt proteinuria', 'interventionNames': ['Drug: Telmisartan 80 mg/d']}, {'label': 'B', 'description': 'Subjects with type 2 diabetes mellitus, eGFR \\> 80, hypertension, no overt proteinuria', 'interventionNames': ['Drug: Ramipril 10 mg/d']}], 'interventions': [{'name': 'Telmisartan 80 mg/d', 'type': 'DRUG', 'armGroupLabels': ['A']}, {'name': 'Ramipril 10 mg/d', 'type': 'DRUG', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91054', 'city': 'Erlangen', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'University of Erlangen-Nuremberg', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}], 'overallOfficials': [{'name': 'Roland E Schmieder, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nuremberg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Erlangen-Nürnberg Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}