Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2026-02-22 @ 7:03 PM
Study NCT ID:
NCT03204461
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2017-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glucose Metabolism in Different PCOS Phenotypes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D018149', 'term': 'Glucose Intolerance'}, {'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}], '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': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005951', 'term': 'Glucose Tolerance Test'}, {'id': 'D066244', 'term': 'Proton Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003940', 'term': 'Diagnostic Techniques, Endocrine'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2015-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-27', 'studyFirstSubmitDate': '2017-06-26', 'studyFirstSubmitQcDate': '2017-06-27', 'lastUpdatePostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-07-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of glucose metabolism between PCOS women and healthy control subjects, using data of the OGTT.', 'timeFrame': 'Up to 4 weeks', 'description': 'In the present study the Glucose metabolism in PCOS women and control subjects was assessed with an OGTT. Therefore the dynamic levels of glucose, insulin and C-peptide were assessed during an extended OGTT for the calculation of Insulin resistance and beta-cell function. In addition an 1H-magnetic resonance spectroscopy was done for the assessment of the ectopic lipid content in the liver, heart and the skeletal muscle.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polycystic Ovary Syndrome', 'Glucose Intolerance', 'Liver Fat', 'Glucose Metabolism Disorders']}, 'referencesModule': {'references': [{'pmid': '30158974', 'type': 'DERIVED', 'citation': 'Leutner M, Gobl C, Wolf P, Maruszczak K, Bozkurt L, Steinbrecher H, Just-Kukurova I, Ott J, Egarter C, Trattnig S, Kautzky-Willer A. Pericardial Fat Relates to Disturbances of Glucose Metabolism in Women with the Polycystic Ovary Syndrome, but Not in Healthy Control Subjects. Int J Endocrinol. 2018 Aug 7;2018:5406128. doi: 10.1155/2018/5406128. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'In the present study glucose metabolism and ectopic lipids in the liver, heart and muscle were investigated in women with the polycystic ovary syndrome (PCOS) and in healthy control subjects.', 'detailedDescription': 'In detail an oral glucose tolerance test (OGTT) was conducted in women with the PCOS defined by the Rotterdam and the NIH-criteria, as well as in healthy control subjects. In addition 1H-magnetic resonance spectroscopy and Imaging was used for the assessment of the ectopic lipid content in the liver, heart and skeletal muscle. The aim of the present study was to compare the glucose metabolism and the ectopic lipid conent in the liver, heart and muscle between women with the PCOS defined by the NIH-criteria, Rotterdam-criteria and healthy control subjects.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'In the present study women with the Polycystic Ovary Syndrome, defined according to the NIH-criteria and the Rotterdam criteria were included. The control Group consisted of healthy volunteers without a diagnosis of prediabetes, Diabetes or the PCOS.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with the polycystic ovary Syndrome defined according to the Rotterdam and the NIH-criteria\n* healthy control subjects\n\nExclusion Criteria:\n\n* BMI\\>=40kg/m²\n* Diagnosis of Diabetes in the PCOS-Group\n* Diagnosis of Prediabetes or Diabetes in the control group'}, 'identificationModule': {'nctId': 'NCT03204461', 'briefTitle': 'Glucose Metabolism in Different PCOS Phenotypes', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Associatons of PCOS Phenotypes With Ectopic Lipids, Adipocytokines and Parameters of Insulin Resistance', 'orgStudyIdInfo': {'id': 'PCOS-1090'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PCOS-NIH', 'interventionNames': ['Diagnostic Test: Oral glucose tolerance test (OGTT)', 'Other: 1H-magnetic resonance spectroscopy']}, {'label': 'PCOS-Rotterdam', 'interventionNames': ['Diagnostic Test: Oral glucose tolerance test (OGTT)', 'Other: 1H-magnetic resonance spectroscopy']}, {'label': 'Controls', 'interventionNames': ['Diagnostic Test: Oral glucose tolerance test (OGTT)', 'Other: 1H-magnetic resonance spectroscopy']}], 'interventions': [{'name': 'Oral glucose tolerance test (OGTT)', 'type': 'DIAGNOSTIC_TEST', 'description': 'For the assessment of glucose metabolism, including beta-cell function and insulin sensitivity an 75g-OGTT was conducted.', 'armGroupLabels': ['Controls', 'PCOS-NIH', 'PCOS-Rotterdam']}, {'name': '1H-magnetic resonance spectroscopy', 'type': 'OTHER', 'description': 'The amount of ectopic lipids in the liver, heart and the skeletal muscle was measured using 1H-magnetic resonance spectroscopy.', 'armGroupLabels': ['Controls', 'PCOS-NIH', 'PCOS-Rotterdam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Alexandra Kautzky-Willer, Univ.Prof.Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Internal Medicine III, Clinical Division of Endocrinology and Metabolism, Unit of Gender Medicine, Medical University of Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Univ.Prof.Dr.', 'investigatorFullName': 'Alexandra Kautzky-Willer', 'investigatorAffiliation': 'Medical University of Vienna'}}}}