Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-27 @ 7:13 AM
Study NCT ID:
NCT00694759
Status:
COMPLETED
Last Update Posted:
2019-09-09
First Post:
2008-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cortisol Regulation in Polycystic Ovary Syndrome (PCOS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-08-27', 'releaseDate': '2020-08-13'}], 'estimatedResultsFirstSubmitDate': '2020-08-13'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077205', 'term': 'Pioglitazone'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-05', 'studyFirstSubmitDate': '2008-06-06', 'studyFirstSubmitQcDate': '2008-06-09', 'lastUpdatePostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The comparison of body surface area adjusted cortisol production rate (CPR/BSA) before insulin sensitizing therapy in women with PCOS.', 'timeFrame': 'Before 6 months of insulin sensitizing therapy'}, {'measure': 'The comparison of body surface area adjusted cortisol production rate (CPR/BSA) after insulin sensitizing therapy in women with PCOS.', 'timeFrame': 'After 6 months of insulin sensitizing therapy'}], 'secondaryOutcomes': [{'measure': 'Comparisons of 24-hour values for adrenocorticotropic hormone , free-cortisol, and cortisol binding globulin.', 'timeFrame': 'Before 6 months of insulin sensitizing therapy'}, {'measure': 'Comparisons of 24-hour values for adrenocorticotropic hormone , free-cortisol, and cortisol binding globulin.', 'timeFrame': 'After 6 months of insulin sensitizing therapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Polycystic ovary syndrome', 'insulin', 'PCOS', 'cortisol regulation', 'regulation'], 'conditions': ['Polycystic Ovary Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if insulin resistance (how well the body uses insulin and clears sugar) can affect cortisol levels in normal healthy women and women with polycystic ovary syndrome of all body weights.', 'detailedDescription': 'PCOS is a common clinical problem affecting young women, characterized by oligomenorrhea and hyperandrogenism. Central obesity and insulin resistance are also prominent features of PCOS, and in addition are important risk factors for development of hypertension, hyperlipidemia and atherosclerotic heart disease. Previous studies have suggested that cortisol is dysregulated in PCOS, primarily through increased hypothalamic-pituitary-adrenal (HPA) axis activity and enhanced cortisol secretion. Increased adrenocorticotropic hormone (ACTH) secretion could also potentially lead to elevated adrenal androgen production in PCOS. Techniques used in previous studies have been inconsistent, however, and a link between increased HPA axis activity and the phenotypic changes in PCOS has not been clearly demonstrated. Cortisol is also produced from cortisone in peripheral adipose tissue by the enzyme 11beta-hydroxysteroid dehydrogenase type 1 (HSD 1), suggesting another potential point of dysregulation that may contribute to central obesity and insulin resistance in PCOS. Further investigation of both central and peripheral regulation of cortisol is necessary to better understand the pathophysiology of PCOS.\n\nSpecific Aim 1: To perform a cross-sectional study of women with PCOS and normal controls matched for age and body mass index, and measure insulin sensitivity and visceral fat, as well as (a) 24-hour CPR, ACTH, free cortisol, and cortisol binding globulin (CBG), (b) adipocyte, liver, and whole body HSD 1 activity, and (c) androgen levels.\n\nSpecific Aim 2: To prospectively administer pioglitazone or metformin to women with PCOS in a placebo-controlled trial, and after one month and six months of therapy measure (a) 24-hour CPR, ACTH, free cortisol, and CBG, (b) adipocyte, liver, and whole body HSD 1 activity, and (c) insulin sensitivity, visceral fat, and androgen levels.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (Healthy controls):\n\n* Healthy\n* At lifetime maximal weight\n* Weight stable for at least 6 months prior to study entry\n* Willing to commit to not making significant changes to their diet or daily activities while enrolled.\n* Premenopausal\n* Have regular menstrual cycles\n* No evidence of hirsutism\n\nAdditional Inclusion Criteria (Subjects with PCOS):\n\n* Clinical findings of amenorrhea or oligomenorrhea dating from menarche\n* Clinical and/or biochemical evidence of hyperandrogenism\n* Exclusion of related disorders\n\nExclusion Criteria (Healthy controls):\n\n* Less than 18 years of age\n* Exercise \\> 30 minutes/day, 3 times a week\n* Smokers\n* Heavy alcohol drinkers (\\> 2 drinks/day)\n* Type 2 diabetes\n* Medical diagnoses including heart disease and cancer\n* Psychiatric illness (i.e.depression, psychosis, bipolar, schizophrenia)\n* Body weight \\> 136 kg\n* Pregnant\n* Endocrine diseases affecting body composition or androgen levels\n\nAdditional Exclusion Criteria (Subjects with PCOS):\n\n* Laboratory evidence of hyperprolactinemia, thyroid dysfunction, or 21-hydroxylase-deficient nonclassic CAH\n* Contraindication to pioglitazone (i.e. CHF, impaired liver function, anemia, depressed leukocyte counts, pulmonary disease, known sensitivity to thiazolidinediones.'}, 'identificationModule': {'nctId': 'NCT00694759', 'briefTitle': 'Cortisol Regulation in Polycystic Ovary Syndrome (PCOS)', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Cortisol Regulation in Polycystic Ovary Syndrome', 'orgStudyIdInfo': {'id': 'OHSUIRB00002532'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'Pioglitazone will be given to women with PCOS. After one month and six months of therapy, measure (a) 24-hour CPR, ACTH, free cortisol, and CBG, (b) adipocyte, liver, and whole body HSD 1 activity, and (c) insulin sensitivity, visceral fat, and androgen levels.', 'interventionNames': ['Drug: pioglitazone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'Metformin will be given to women with PCOS. After one month and six months of therapy, measure (a) 24-hour CPR, ACTH, free cortisol, and CBG, (b) adipocyte, liver, and whole body HSD 1 activity, and (c) insulin sensitivity, visceral fat, and androgen levels.', 'interventionNames': ['Drug: metformin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'C', 'description': 'Placebo will be given to women with PCOS. After one month and six months of therapy, measure (a) 24-hour CPR, ACTH, free cortisol, and CBG, (b) adipocyte, liver, and whole body HSD 1 activity, and (c) insulin sensitivity, visceral fat, and androgen levels.', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'pioglitazone', 'type': 'DRUG', 'otherNames': ['Actos'], 'description': '30 mg for 2 weeks, then 45 mg daily', 'armGroupLabels': ['A']}, {'name': 'metformin', 'type': 'DRUG', 'otherNames': ['Glucophage', 'Glucophage XR'], 'description': '500mg twice daily for 1 week, then 1000 mg twice daily', 'armGroupLabels': ['B']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'capsule twice daily', 'armGroupLabels': ['C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Bethany J. Klopfenstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Bethany Klopfenstein', 'investigatorAffiliation': 'Oregon Health and Science University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-08-13', 'type': 'RELEASE'}, {'date': '2020-08-27', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Bethany Klopfenstein, Principal Investigator, Oregon Health and Science University'}}}}