Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2026-01-05 @ 1:46 PM
Study NCT ID:
NCT00473603
Status:
COMPLETED
Last Update Posted:
2018-01-25
First Post:
2007-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Free Fatty Acids (FFA) on Androgen Precursors in Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017588', 'term': 'Hyperandrogenism'}], 'ancestors': [{'id': 'D058489', 'term': '46, XX Disorders of Sex Development'}, {'id': 'D012734', 'term': 'Disorders of Sex Development'}, {'id': 'D014564', 'term': 'Urogenital Abnormalities'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D047808', 'term': 'Adrenogenital Syndrome'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-23', 'studyFirstSubmitDate': '2007-05-14', 'studyFirstSubmitQcDate': '2007-05-14', 'lastUpdatePostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of DHEA', 'timeFrame': '1 day', 'description': 'Measurement of serum DHEA'}, {'measure': 'change of DHEAS', 'timeFrame': '1 day', 'description': 'Measurement of serum DHEAS'}, {'measure': 'change of testosterone', 'timeFrame': '1 day', 'description': 'Measurement of serum testosterone'}, {'measure': 'change of androstenedione', 'timeFrame': '1 day', 'description': 'Measurement of serum androstenedione'}], 'secondaryOutcomes': [{'measure': 'urinary androgen excretion', 'timeFrame': '1 day'}, {'measure': 'urinary cortisol excretion', 'timeFrame': '1 day', 'description': 'measurement of urinary cortisol, aTHF and THF'}, {'measure': 'urinary cortisone excretion', 'timeFrame': '1 day', 'description': 'measurement of urinary cortisone and THE'}, {'measure': 'changes in metabolic parameters (e.g. FGF-21)', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['androgens', 'fatty acids'], 'conditions': ['Hyperandrogenism', 'Glucocorticoid Metabolism']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether free fatty acids modify the androgen levels in healthy young women.', 'detailedDescription': 'Free fatty acids (FFA) are known to play an important role by inducing insulin resistance and metabolic disturbances in obesity and type 2 diabetes. In addition, FFAs seems to have a stimulatory effect on adrenal androgen precursors in men. However, the effect of FFAs on androgen precursors and androgens in women is yet unknown.\n\nTherefore the effect of increased FFAs on adrenal androgens and androgen precursors should be investigated in a randomized controlled cross-over trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy men and women\n\nExclusion Criteria:\n\n* diabetes mellitus or impaired glucose tolerance\n* clinical signs of hyperandrogenism\n* polycystic ovary\n* hormonal therapy\n* BMI \\> 30 kg/m2\n* dysmenorrhoea'}, 'identificationModule': {'nctId': 'NCT00473603', 'briefTitle': 'Effect of Free Fatty Acids (FFA) on Androgen Precursors in Women', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Effect of Free Fatty Acids on Androgen Precursors in Vivo in Healthy Young Women', 'orgStudyIdInfo': {'id': '201-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LHI', 'description': 'to perform an i.v. lipid heparin infusion for 4 h', 'interventionNames': ['Drug: lipid/heparin infusion']}, {'type': 'SHAM_COMPARATOR', 'label': 'SHI', 'description': 'to perform an i.v. saline heparin infusion for 4 h', 'interventionNames': ['Drug: lipid/heparin infusion']}], 'interventions': [{'name': 'lipid/heparin infusion', 'type': 'DRUG', 'description': 'to perform an i.v. lipid heparin infusion infusion for 4 h', 'armGroupLabels': ['LHI', 'SHI']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite, Campus Benjamin Franklin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Knut Mai, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Professor Joachim Spranger', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}