Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-25 @ 3:18 PM
Study NCT ID:
NCT01195168
Status:
COMPLETED
Last Update Posted:
2010-09-06
First Post:
2010-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiovascular Risk Markers in Polycystic Ovary Syndrome (PCOS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 201}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-03', 'studyFirstSubmitDate': '2010-09-02', 'studyFirstSubmitQcDate': '2010-09-03', 'lastUpdatePostDateStruct': {'date': '2010-09-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of Insulin resistance in women with PCOS compared with BMI and age matched controls', 'timeFrame': 'Recruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasion', 'description': 'Subjects underwent a standard 75g oral glucose tolerance test (OGTT) and blood were taken fasting and at 2 hours. Surrogate markers of insulin resistance (HOMA) and insulin sensitivity (Avignon index of Insulin Sensitivity; QUICKI) were calculated'}], 'secondaryOutcomes': [{'measure': 'Assessment of concentrations of androgens in women with PCOS compared with controls', 'timeFrame': 'Recruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasion', 'description': 'Bloods were taken in the fasted state and circulating concentrations of androgens (DHEAS, testosterone, androstenedione) were assessed'}, {'measure': 'Assessment of lipid profile in women with PCOS compared with age matched controls', 'timeFrame': 'Recruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasion', 'description': 'Bloods were taken in the fasted state and circulating concentrations of lipids assessed'}, {'measure': 'Assessment of inflammatory profile in women with PCOS compared with controls', 'timeFrame': 'Recruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasion', 'description': 'Bloods were taken in the fasted state and circulating concetrations of several important markers of inflammation as well as key adipokines were assessed'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PCOS'], 'conditions': ['Polycystic Ovary Syndrome']}, 'referencesModule': {'references': [{'pmid': '24842896', 'type': 'DERIVED', 'citation': "Gidwani S, Phelan N, McGill J, McGowan A, O'Connor A, Young IS, Gibney J, McEneny J. Polycystic ovary syndrome influences the level of serum amyloid A and activity of phospholipid transfer protein in HDL(2) and HDL(3). Hum Reprod. 2014 Jul;29(7):1518-25. doi: 10.1093/humrep/deu115. Epub 2014 May 19."}, {'pmid': '21270384', 'type': 'DERIVED', 'citation': "Phelan N, O'Connor A, Kyaw Tun T, Correia N, Boran G, Roche HM, Gibney J. Hormonal and metabolic effects of polyunsaturated fatty acids in young women with polycystic ovary syndrome: results from a cross-sectional analysis and a randomized, placebo-controlled, crossover trial. Am J Clin Nutr. 2011 Mar;93(3):652-62. doi: 10.3945/ajcn.110.005538. Epub 2011 Jan 26."}]}, 'descriptionModule': {'briefSummary': 'Women with polycystic ovary syndrome (PCOS) are more often overweight or obese and are more insulin resistant than women without the condition and may be at greater risk of developing cardiovascular disease. It is not know whether it is the overweight and insulin resistant component of PCOS, or PCOS per se which leads to the greater cardiovascular disease risk. The aim of this study was to examine cardiovascular risk markers in women with PCOS versus a control population matched for body mass index (BMI), and or, insulin resistance'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women with PCOS and a control population of women matched for age and body mass index (BMI) and insulin resistance', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Had a positive diagnosis of PCOS as defined according to the NIH criteria as chronic oligomenorrhoea (\\< 9 menstrual cycles per year) and clinical and/or biochemical evidence of hyperandrogenism, in the absence of other disorders causing the same phenotype. Clinical criteria included hirsutism with a Ferriman-Galwey score greater than 9, acne or male pattern alopecia; biochemical criteria included total-testosterone, androstenedione or dehydroepiandrosterone sulphate (DHEAS) greater than the laboratory reference range.\n* Were between the ages of 18 and 40\n\nExclusion Criteria:\n\n* Were under 18 years or greater than 40 years old,\n* Were non-Caucasian\n* Were pregnant, lactating or trying to conceive\n* Had a body mass index (BMI) \\<18kg/m2 or \\>50kg/m2\n* Had a recent illness or any chronic illness likely to influence results\n* Were taking hormonal contraception'}, 'identificationModule': {'nctId': 'NCT01195168', 'acronym': 'CS', 'briefTitle': 'Cardiovascular Risk Markers in Polycystic Ovary Syndrome (PCOS)', 'organization': {'class': 'OTHER', 'fullName': 'The Adelaide and Meath Hospital'}, 'officialTitle': 'Assessment of Cardiovascular Risk in PCOS-a Cross Sectional Study of Women With PCOS Compared With Controls Matched for Age, Body Mass Index and, or Insulin Resistance', 'orgStudyIdInfo': {'id': 'DDC-UCD-CS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PCOS cohort', 'description': 'Women with PCOS as diagnosed by the NIH criteria'}, {'label': 'Control cohort', 'description': 'Women without PCOS'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'Dublin 24', 'city': 'Dublin', 'state': 'Leinster', 'country': 'Ireland', 'facility': 'Diabetes Day Centre, The Adelaide and Meath Hosptial', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': 'Dublin 4', 'city': 'Dublin', 'state': 'Leinster', 'country': 'Ireland', 'facility': 'Nutrigenomics Research Group, University College Dublin', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}], 'overallOfficials': [{'name': 'James Gibney, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Adelaide and Meath Hospital'}, {'name': 'Helen M Roche, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University College Dublin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Adelaide and Meath Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University College Dublin', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr James Gibney', 'oldOrganization': "The Adelaide and Meath Hospital Incorporating the National Children's Hospital"}}}}