Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-28 @ 11:41 AM
Study NCT ID:
NCT01295892
Status:
COMPLETED
Last Update Posted:
2013-04-18
First Post:
2011-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronic Effects of Estrogen in Microcirculation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004967', 'term': 'Estrogens'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-17', 'studyFirstSubmitDate': '2011-02-14', 'studyFirstSubmitQcDate': '2011-02-14', 'lastUpdatePostDateStruct': {'date': '2013-04-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'functional capillary density by videocapillaroscopy(number of perfused capillaries on the studied skin area)', 'timeFrame': '03 months'}], 'secondaryOutcomes': [{'measure': 'blood viscosity(the values are expressed in centipoises)', 'timeFrame': '03 months', 'description': 'evaluate the change in blood viscosity after 3 months of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['menopause', 'obesity', 'capillary', 'microcirculation', 'estrogen', 'Microvascular Function'], 'conditions': ['Postmenopausal Symptoms']}, 'referencesModule': {'references': [{'pmid': '27170466', 'type': 'DERIVED', 'citation': 'da Silva LH, Panazzolo DG, Marques MF, Souza MG, Paredes BD, Nogueira Neto JF, Leao LM, Morandi V, Bouskela E, Kraemer-Aguiar LG. Low-dose estradiol and endothelial and inflammatory biomarkers in menopausal overweight/obese women. Climacteric. 2016 Aug;19(4):337-43. doi: 10.1080/13697137.2016.1180676. Epub 2016 May 12.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the chronic effects of estrogen on microcirculation, inflammatory biomarkers, hormonal status, plasma viscosity and biochemical tests in postmenopausal obese women after three months of follow-up intervention.', 'detailedDescription': "Estrogens exert pleiotropic actions on the cardiovascular system through binding to estrogen receptors. Traditionally, estrogen receptors have been recognized as transcription factors regulating the expression of target genes, however, numerous studies have revealed rapid actions of estrogen in different systems, so-called 'extranuclear actions'. At this level, estrogen triggers rapid vasodilatation, exerts anti-inflammatory effects, regulates vascular cell growth and migration, and confers protection to cardiomyocytes. Our aims are to investigate estrogen´s chronic effects on microcirculation.\n\nThe study will assess the potential benefits of estrogens on: chronic low-grade inflammation, metabolic profile, microcirculation and blood rheology. Postmenopausal obese women will be randomly submitted to estrogen (transdermal 17-β-estradiol 1mg/day) or placebo therapy during three months in a double-blind fashion. At baseline and after intervention, nailfold videocapillaroscopy, laser-Doppler flowmetry and venous occlusion plethysmography, inflammatory biomarkers, hormonal status, metabolic profile, plasma viscosity and anthropometrical measures will be assessed in all subjects."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '48 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of natural menopause defined by the absence of menses for at least 12 months and a serum concentration of FSH \\> 35 IU/L\n* BMI between 27 to 34.9 kg/m²\n* Non-smokers\n* Not on use of any hormones or supplements for a minimum of 6 months prior to the study\n* No absolute contraindications to the use of physiological replacement doses of estrogen\n\nExclusion Criteria:\n\n* Renal disease, coronary or peripheral vascular diseases, haematologic or hepatic diseases\n* Diabetes mellitus, glucose intolerance or altered fasting glucose'}, 'identificationModule': {'nctId': 'NCT01295892', 'briefTitle': 'Chronic Effects of Estrogen in Microcirculation', 'organization': {'class': 'OTHER', 'fullName': 'Rio de Janeiro State University'}, 'officialTitle': 'Chronic Effects of Estrogen in Microcirculation and Insulin Resistance in Postmenopausal Obese Women', 'orgStudyIdInfo': {'id': 'pkvw6k'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo (transdermal gel)', 'interventionNames': ['Drug: Estrogen']}, {'type': 'EXPERIMENTAL', 'label': 'Estrogen', 'description': '1mg of 17B-estradiol/day (transdermal gel)', 'interventionNames': ['Drug: Estrogen']}], 'interventions': [{'name': 'Estrogen', 'type': 'DRUG', 'description': 'transdermal 17-β-estradiol 1mg/day during three months', 'armGroupLabels': ['Estrogen', 'placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Laboratorio de Pesquisas Clinicas e Experimentais em Biologia Vascular', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}], 'overallOfficials': [{'name': 'Diogo Panazzolo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rio de Janeiro State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rio de Janeiro State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chronic Effects of Estrogen in Microcirculation and Insulin Resistance in Postmenopausal Obese Women', 'investigatorFullName': 'Luiz Guilherme Kraemer de Aguiar', 'investigatorAffiliation': 'Rio de Janeiro State University'}}}}