Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-25 @ 2:29 PM
Study NCT ID:
NCT03583866
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-06
First Post:
2018-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adiposity and Endothelin Receptor Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C081643', 'term': 'candesartan'}, {'id': 'C077793', 'term': 'candesartan cilexetil'}, {'id': 'D008320', 'term': 'Maltose'}], 'ancestors': [{'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D004187', 'term': 'Disaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-05', 'studyFirstSubmitDate': '2018-06-27', 'studyFirstSubmitQcDate': '2018-07-10', 'lastUpdatePostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage Change in Flow-Mediated Dilation (FMD)', 'timeFrame': 'pre-treatment Baseline and 7 days post-treatment', 'description': 'Change in Brachial artery FMD induced by reactive hyperemia assessed vascular endothelial function at baseline and several hours after treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['blood pressure', 'microdialysis'], 'conditions': ['Hypertension']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://facebook.com/harrislab', 'label': 'Laboratory of Integrative and Exercise Physiology Website'}]}, 'descriptionModule': {'briefSummary': 'Elevated levels of ET-1 have been implicated in cardiovascular disease and some forms of hypertension. Due to the strong, positive correlation between obesity and hypertension, the present study will explore the contribution of adiposity in ETB receptor function and aim to elucidate if ETB receptor dysfunction is a major contributor to hypertension in obesity.', 'detailedDescription': 'The proposed study is designed to investigate the influence of adiposity on ETB receptor function and subsequent vascular responses. The combination of ET-1, ET-3, and the respective ETA and ETB receptor antagonists will be used to provide insight into the mechanisms of ETB receptor dysfunction in the presence of adiposity. Previous studies have revealed elevations in circulating ET-1 in obese individuals; therefore, we predict that obese subjects will exhibit 1) ETB receptor dysfuncton compared to lean subjects and 2) an improvement in ETB receptor dysfunction following treatment with Candesartan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• If you are an adult between the ages of 18-40 year old\n\nExclusion Criteria:\n\n* Evidence of cardiovascular, pulmonary, renal, hepatic, cerebral, or metabolic disease\n* Evidence of pregnancy\n* Using medications that affect vascular tone (i.e., nitrates, etc.)\n* Use of any anticoagulants (i.e. aspirin)\n* Anemia\n* If you are postmenopausal\n* If you have uncontrolled hypertension (treated resting SBP \\>140 mm Hg or DBP \\>90 mm Hg)'}, 'identificationModule': {'nctId': 'NCT03583866', 'acronym': 'END-RF', 'briefTitle': 'Adiposity and Endothelin Receptor Function', 'organization': {'class': 'OTHER', 'fullName': 'Augusta University'}, 'officialTitle': 'Adiposity and Endothelin Receptor Function', 'orgStudyIdInfo': {'id': '1148277'}, 'secondaryIdInfos': [{'id': '5P01HL069999', 'link': 'https://reporter.nih.gov/quickSearch/5P01HL069999', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Candesartan', 'description': 'Sub chronic (7 days) Candesartan (16 mg/day)', 'interventionNames': ['Drug: Candesartan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Endothelial function will be determined following a seven day treatment of placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Candesartan', 'type': 'DRUG', 'otherNames': ['Blopress, Atacand, Amias, and Ratacand'], 'description': '7 days of Candesartan (16mg/day)', 'armGroupLabels': ['Candesartan']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Lactose capsule, Maltose capsule'], 'description': '7 days of Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Prevention Institute/ Laboratory of Integrative and Exercise Physiology', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}], 'overallOfficials': [{'name': 'Ryan Harris, PHD, CES', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Augusta University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Augusta University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ryan Harris', 'investigatorAffiliation': 'Augusta University'}}}}