Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2026-03-28 @ 2:23 AM
Study NCT ID:
NCT05312892
Status:
RECRUITING
Last Update Posted:
2025-02-25
First Post:
2022-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sympathetic Mechanisms in Obesity-Crossover Design
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017311', 'term': 'Amlodipine'}, {'id': 'D000959', 'term': 'Antihypertensive Agents'}, {'id': 'C043482', 'term': 'moxonidine'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002317', 'term': 'Cardiovascular Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-23', 'studyFirstSubmitDate': '2022-03-28', 'studyFirstSubmitQcDate': '2022-04-05', 'lastUpdatePostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endogenous glucose production', 'timeFrame': 'During two-step insulin clamp (six hours)', 'description': 'Rate of appearance and disappearance of labeled glucose'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Hypertension']}, 'descriptionModule': {'briefSummary': 'We will study obese hypertensive subjects in a randomized, crossover study to determine if two weeks sympathetic blockade improves endogenous glucose production. Subjects will be studied on 3 different occasions after two weeks of receiving either placebo, amlodipine (vasodilator arm) or moxonidine (study arm). The order of the studies will be determined using computer-generated randomization. Patients will be blinded as to which treatment they are receiving on each day. An investigator blinded to the treatment assignment will perform the analysis of the data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males and females of all races between 18 and 65 years of age\n* Hypertension defined by two or more properly measured seated blood pressure readings \\>130/85 mmHg or currently on antihypertensive medication.\n* Obesity will be defined as having a body mass index (BMI) ≥ 30 kg/m2.\n* Able and willing to provide informed consent.\n\nExclusion Criteria:\n\n* Pregnancy or breast feeding\n* Current smokers or history of heavy smoking (\\>2 packs/day)\n* History of alcohol or drug abuse\n* Previous allergic reaction to study medications\n* Type I diabetes.\n* Cardiovascular disease other than hypertension such as myocardial infarction within 6 months prior to enrollment, presence of angina pectoris, significant arrhythmia, congestive heart failure (LV hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis, or hypertrophic cardiomyopathy\n* History of serious cerebrovascular disease such as cerebral hemorrhage, stroke, or transient ischemic attack\n* History or presence of immunological or hematological disorders\n* Impaired renal function\n* Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in 1 month)\n* Treatment with any investigational drug in the 1 month preceding the study\n* Inability to give, or withdraw, informed consent\n* Other factors which in the investigator's opinion would prevent the subject from completing the protocol (i.e., clinically significant abnormalities on clinical, mental examination or laboratory testing or inability to comply with protocol, inability to find IV access)"}, 'identificationModule': {'nctId': 'NCT05312892', 'briefTitle': 'Sympathetic Mechanisms in Obesity-Crossover Design', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Sympathetic Mechanisms in the Cardiovascular and Metabolic Alterations of Obesity, Crossover Design Study.', 'orgStudyIdInfo': {'id': '212413'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects will received 2 weeks of capsules containing placebo.', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Amlodipine', 'description': 'Subjects will received 2 weeks of capsules containing amlodipine.', 'interventionNames': ['Drug: Amlodipine']}, {'type': 'EXPERIMENTAL', 'label': 'Moxonidine', 'description': 'Subjects will received 2 weeks of capsules containing moxonidine.', 'interventionNames': ['Drug: Moxonidine']}], 'interventions': [{'name': 'Amlodipine', 'type': 'DRUG', 'otherNames': ['Antihypertensive'], 'description': 'Subjects will receive either an antihypertensive (amlodipine or moxonidine) medication or placebo for two weeks, then cross over to the second arm, and then after 2 weeks of the second drug/placebo, will be switched to the third arm.', 'armGroupLabels': ['Amlodipine']}, {'name': 'Moxonidine', 'type': 'DRUG', 'otherNames': ['Antihypertensive'], 'description': 'Moxonidine', 'armGroupLabels': ['Moxonidine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cynthia Laws, MS', 'role': 'CONTACT', 'email': 'autonomicgroup@vumc.org', 'phone': '615-421-1994'}, {'name': 'Alfredo Gamboa, MD', 'role': 'CONTACT', 'email': 'alfredo.gamboa@vumc.org'}, {'name': 'Italo Biaggioni, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Italo Biaggioni', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}