Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-02-24 @ 8:25 AM
Study NCT ID:
NCT02244567
Status:
UNKNOWN
Last Update Posted:
2021-02-02
First Post:
2014-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Metformin Therapy on Serum Under-carboxylated Osteocalcin Levels in Hyperandrogenic Lean Polycystic Ovarian Syndrome Women
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D014815', 'term': 'Vitamins'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D018977', 'term': 'Micronutrients'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000078622', 'term': 'Nutrients'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-30', 'studyFirstSubmitDate': '2014-09-13', 'studyFirstSubmitQcDate': '2014-09-18', 'lastUpdatePostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'High Serum under-carboxylated osteocalcin', 'timeFrame': '3 months', 'description': 'Hyperandrogenic lean women will be diagnosed as PCOS according to Androgen Excess-Polycystic Ovary Syndrome (AE-PCOS) Society 2006 criteria.Serum uc-oc will be assayed when it is found to be high, metformin therapy for three months will be given to these women. Serum uc-oc will be measured again and effect of therapy will be interpreted.'}], 'secondaryOutcomes': [{'measure': 'Metformin therapy', 'timeFrame': '3 months', 'description': 'Cidophage 850 mg twice daily will be given for three months to pcos patients who are hyperandrogenic and lean then serum uc-oc will be measured after therapy.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PCOS'], 'conditions': ['Polycystic Ovarian Syndrome']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/', 'label': 'Pepene CE. Serum under-carboxylated osteocalcin levels in women with polycystic ovary syndrome: weight-dependent relationships with endocrine and metabolic traits. J Ovarian Res. 2013;6(1):4.'}]}, 'descriptionModule': {'briefSummary': 'High ucOC may favor insulin release in lean hyperandrogenic women to compensate for impaired insulin sensitivity. Meformin is an insulin sensitizing agent will be given for these women trying to interfere with the pathophysiology of PCOS in these women as followed up by serum UC-OC levels.', 'detailedDescription': 'Under-carboxylated osteocalcin (ucOC), the precursor substrate of bone biomarker OC is a potent regulator of energy metabolism by promoting insulin production and adiponectin synthesis and decreasing fat stores.UcOC has a potential role in the physiopathology of polycystic ovary syndrome (PCOS), a common disorder defined by the constellation of anovulation, insulinresistance, hyperinsulinemia, obesity and androgen excess.Circulating ucOC concentration is related to key endocrine PCOS characteristics in a weight-dependent manner. Within the bone-pancreas loop, high ucOC may favor insulin release in lean hyperandrogenic women to compensate for impaired insulin sensitivity.We will investigate serum uc-OC responses to insulin sensitizing therapies in lean hyperandrogenic polycystic ovary syndrome (PCOS).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lean women BMI 25 or less\n* Hyperandrogenic clinically and/or biochemically.\n* Androgen Excess-Polycystic Ovary Syndrome (AE-PCOS) Society 2006 criteria\n\nExclusion Criteria:\n\n* BMI more than 20\n* Other causes of hyperandrogenism\n* Other causes of metabolic disorders or diabetes.'}, 'identificationModule': {'nctId': 'NCT02244567', 'acronym': 'U-C OC IN PCOS', 'briefTitle': 'Effect of Metformin Therapy on Serum Under-carboxylated Osteocalcin Levels in Hyperandrogenic Lean Polycystic Ovarian Syndrome Women', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'Effect of Metformin Therapy on Serum Under-carboxylated Osteocalcin in Hyperandrogenic Lean PCOS Women', 'orgStudyIdInfo': {'id': 'Beni-Suef 4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin', 'description': 'Cidophage 850 mg twice daily for three months will be given to the patientwith PCOS.', 'interventionNames': ['Drug: Metformin 850 mg twice daily for 3 months']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Serum under-carboxylated osteocalcin', 'description': 'Serum uc-oc will be measured before and after 3 months of treatment with cidophage.', 'interventionNames': ['Procedure: Serum uc-oc']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo', 'description': 'Other group of patients with high serum UC-OC will be given a placebo.', 'interventionNames': ['Other: drug']}], 'interventions': [{'name': 'Metformin 850 mg twice daily for 3 months', 'type': 'DRUG', 'otherNames': ['Cidophage'], 'description': 'This drug is insulin sensitizing agent which will be given twice daily orally for 3 months for PCOS patients.', 'armGroupLabels': ['Metformin']}, {'name': 'Serum uc-oc', 'type': 'PROCEDURE', 'otherNames': ['Serum undercarboxylated-osteocalcin'], 'description': 'Serum uc-oc is a bone biomarker involved in incraesing insulin in pathophysiology of PCOS. It will be measured in serum of pcos patients before and after treatment with metformin for 3 months.', 'armGroupLabels': ['Serum under-carboxylated osteocalcin']}, {'name': 'drug', 'type': 'OTHER', 'otherNames': ['vitamin'], 'description': 'This group of patients will receive any type of vitamin as a placebo to compare with effect of Metformin on serum UC-OC.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Nesreen A Shehata, MD', 'role': 'CONTACT', 'email': 'nesoomar@yahoo.com', 'phone': '00201227866337'}], 'facility': 'Nesreen Abdel Fattah Abdullah Shehata', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Nesreen A Shehata, MD', 'role': 'CONTACT', 'email': 'nesoomar@yahoo.com', 'phone': '00201227866337'}, {'name': 'Abdelgany M Hassan, MD', 'role': 'CONTACT', 'email': 'abdelgany2@gmail.com', 'phone': '00201017801604'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beni-Suef University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cairo University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Obstetrics and Gynecology', 'investigatorFullName': 'Nesreen Abdel Fattah Abdullah Shehata', 'investigatorAffiliation': 'Beni-Suef University'}}}}