Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2025-12-25 @ 9:05 PM
Study NCT ID:
NCT00552292
Status:
UNKNOWN
Last Update Posted:
2016-12-06
First Post:
2007-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Complications in Hypertension and Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D006943', 'term': 'Hyperglycemia'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, urine, serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-05', 'studyFirstSubmitDate': '2007-10-31', 'studyFirstSubmitQcDate': '2007-10-31', 'lastUpdatePostDateStruct': {'date': '2016-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cardiovascular complications', 'timeFrame': '2007-2017'}], 'secondaryOutcomes': [{'measure': 'diabetes mellitus', 'timeFrame': '2007-2017'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['metabolic syndrome', 'hypertension', 'obesity', 'dyslipidemia', 'hyperglycemia', 'cardiovascular complications'], 'conditions': ['Metabolic Syndrome', 'Hypertension', 'Obesity', 'Dyslipidemia', 'Hyperglycemia']}, 'descriptionModule': {'briefSummary': 'The study in aimed to investigate epidemiology of risk factors in Russian Federation its prognostic value aimed on acceptance of national specific definition of metabolic syndrome and guidelines for its management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Age and sex-matched sample of subjects older 18 age', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age older 18 years\n* Signed informed consent\n* Blood pressure more than 130 and/or 85 mm Hg\n* Waist circumference more than 80 sm in females and 94 in males and/or BMI more than 25 kg/m2\n* Dyslipidemia (elevated TG and/or decreased level of HDLP or therapy for high triglyceride level)\n* Fasting glucose more than 5,6 mmol/l\n\nExclusion Criteria:\n\n* Associated clinical conditions (stroke, TIA, MI, heart failure, renal disease, diabetes mellitus)\n* Severe concomitant diseases affecting outcome'}, 'identificationModule': {'nctId': 'NCT00552292', 'briefTitle': 'Complications in Hypertension and Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health'}, 'officialTitle': 'National Investigation of Cardiovascular Complications in Arterial Hypertension and Obesity', 'orgStudyIdInfo': {'id': '25/1'}}, 'contactsLocationsModule': {'locations': [{'zip': '194156', 'city': 'Saint Petersburg', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Oxana P Rotari, MD', 'role': 'CONTACT', 'email': 'rotariox@mail.ru', 'phone': '7-812-7025556'}, {'name': 'Oxana Rotari, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Almazov Federal Center of Heart, Blood and Endocrinology', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}], 'centralContacts': [{'name': 'Alexandra O Conrady, MD, PhD', 'role': 'CONTACT', 'email': 'ahleague@mail.ru', 'phone': '+7812-70255-71'}, {'name': 'Elena I Baranova, professor', 'role': 'CONTACT', 'email': 'eibaranova@yahoo.com', 'phone': '346-9082', 'phoneExt': '+7812'}], 'overallOfficials': [{'name': 'Eugene V Shlyakhto', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Conrady Alexandra', 'investigatorAffiliation': 'Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health'}}}}