Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-26 @ 11:09 AM
Study NCT ID:
NCT01279512
Status:
COMPLETED
Last Update Posted:
2012-01-06
First Post:
2011-01-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Metformin Versus Acarbose Treatment in Infertile Overweight Women With Polycystic Ovary Syndrome (PCOS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}, {'id': 'D020909', 'term': 'Acarbose'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014312', 'term': 'Trisaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-08', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-05', 'studyFirstSubmitDate': '2011-01-17', 'studyFirstSubmitQcDate': '2011-01-18', 'lastUpdatePostDateStruct': {'date': '2012-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight reduction (BMI improvement)', 'timeFrame': 'After 3 months of Metformin or Acarbose', 'description': 'compare the effect of Metformin and Acarbose to weight reduction'}], 'secondaryOutcomes': [{'measure': 'Fasting blood sugar (FBS)', 'timeFrame': 'two hours post prandial blood sugar', 'description': 'Compare the effect of Metformin and acarbose to fasting blood sugar reduction'}, {'measure': 'FSH', 'timeFrame': '6 months', 'description': 'compare the effect of Metformin and Acarbose to decrease the level of FSH'}, {'measure': 'LH', 'timeFrame': '6 months', 'description': 'compare the effect of Metformin and Acarbose to decrease the level of LH'}, {'measure': 'Estradiol', 'timeFrame': '6 months', 'description': 'compare the effect of Metformin and Acarbose to decrease the Esteradiol level'}, {'measure': 'Prolactin', 'timeFrame': '6 months', 'description': 'compare the effect of Metformin and Acarbose to decrease the Prolactin level'}, {'measure': 'Total testosterone', 'timeFrame': '6 months', 'description': 'compare the the effect of Metformin and Acarbose to decrease Total testosterone level'}, {'measure': 'Total cholesterol', 'timeFrame': '6 months', 'description': 'comparethe the effect of Metformin and Acarbose to decrease total cholesterol level'}, {'measure': 'triglyceride', 'timeFrame': '6 months', 'description': 'comparethe the effect of Metformin and Acarbose to decrease the triglyceride level'}, {'measure': 'High density Lipoprotein', 'timeFrame': '6 months', 'description': 'compare the the effect of Metformin and Acarbose to decrease high density lipoprotein'}, {'measure': 'Low density lipoprotein', 'timeFrame': '6 months', 'description': 'compare the the effect of Metformin and Acarbose to decrease Low Density Lipoprotein'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Metformin Acarbose pco infertility overweight'], 'conditions': ['PCO']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.royaninstitute.org', 'label': 'RoyanInstitute'}]}, 'descriptionModule': {'briefSummary': 'This study is a prospective randomized clinical trial to compare the endocrine and metabolic effects of two anti diabetic drugs (metformin vs. acarbose) in infertile overweight women with PCOS', 'detailedDescription': 'This study is a prospective randomized clinical trial to compare the endocrine and metabolic effects of two anti diabetic drugs (metformin vs. acarbose) in infertile overweight women with PCOS.\n\nPolycystic ovary syndrome (PCOS) is characterized by menstrual irregularity, hyperandrogenism, chronic anovulation and enlarged ovaries with more than twelve peripherally located follicles less than 10 mm in diameter. Hyperinsulinemia is one of the diagnostic features of PCOS and patients with PCOS are found to have resistance to either endogenous or exogenous insulin. Different insulin sensitizing drugs used for improvement of hyperinsulinemia in PCOS subjects. Metformin (N dimethyl-biguanide) is an anti diabetic drug that increases glucose utilization in insulin sensitive tissues. Acarbose is an alfa-Glycosidase inhibitor acts by slowing the absorption of carbohydrates from the intestine, prevents Glucosidase activity in the brush-border of the intestinal mucosa, decreasing disaccharide digestion, reducing enteric monosaccharide absorption, so minimizing the postprandial rise of blood glucose concentration. The aim of present study is to compare the endocrine and metabolic effects of these two antidiabetic drugs (metformin vs. acarbose) in infertile overweight women with PCOS.\n\nThe study population comprises all infertile patients with diagnosis of polycystic ovarian syndrome who were overweight (BMI\\>25Kg/m2). The PCO subjects will be recognized based on the Rotterdam criteria inclusive 1) irregular menstruation, 2) clinical and /or biochemical signs of hyperandrogenism, 3) polycystic ovaries (presence of 12 or more follicles in each ovary measuring 2-9 mm in diameter, and /or increased ovarian volume greater than 10 ml). Diagnosis of PCOS was confirmed by the presence two of three criteria beside the infertility.\n\nIn this study all eligible patients will be randomly allocated into two study groups by a computerized randomization method:\n\nAcarbose group will be treated by acarbose (its dose will be 100 mg/day in the first week, 200 mg/ day in the second week and 300 mg/ day for the next 10 weeks). Metformin group will be received metformin. The metformin dose will be 500 mg/ day in the first week, 1000 mg/ day in the second week and 1500 mg/ day for the next 10 weeks.\n\nData collection will be performed by using questionnaire to be filled as per the available records and laboratory results. This study will be accomplished in Royan Institute on 50 PCO patients (25 patients in each group) and a continuous sampling method will be applied. Data analysis will be done through descriptive and perceptive statistical methods by using SPSS software version 15 for windows.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Poly Cystic Ovarian Syndrome patients\n* Age \\< 40 years\n* BMI \\> 25 kg/m2\n\nExclusion Criteria:\n\n* Smoking\n* Overt diabetes mellitus, hyperprolactinemia, diseases that would disturb clinical and hormonal responses (adrenal disease or tumors, ovarian tumors, thyroid disease)\n* The use of hormonal medications or drugs that might interfere with carbohydrate metabolism over the last 6 months.'}, 'identificationModule': {'nctId': 'NCT01279512', 'briefTitle': 'Metformin Versus Acarbose Treatment in Infertile Overweight Women With Polycystic Ovary Syndrome (PCOS)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Royan Institute'}, 'officialTitle': 'Metformin vs. Acarbose Treatment in Infertile Overweight Women With PCOS: A Prospective Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Royan-Emb-011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metformin reciepiants', 'description': 'Infertile overweight women with PCO who received Metformin', 'interventionNames': ['Drug: Metformin']}, {'type': 'EXPERIMENTAL', 'label': 'Acarbose reciepiants', 'description': 'Infertile overweight women with PCO who received Acarbose', 'interventionNames': ['Drug: Acarbose']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Metformin description'], 'description': 'The metformin dose will be 500 mg/ day in the first week, 1000 mg/ day in the second week and 1500 mg/ day for the next 10 weeks.', 'armGroupLabels': ['Metformin reciepiants']}, {'name': 'Acarbose', 'type': 'DRUG', 'otherNames': ['Acarbose description'], 'description': 'Acarbose group will be treated by acarbose (its dose will be 100 mg/day in the first week, 200 mg/ day in the second week and 300 mg/ day for the next 10 weeks).', 'armGroupLabels': ['Acarbose reciepiants']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'country': 'Iran', 'facility': 'Royan Institute', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Ashraf Moini, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Scientific board'}, {'name': 'Elham Amirchaghmaghi, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Invetigator'}, {'name': 'Zhila Ahmadi, BS.c', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Investigator'}, {'name': 'Bita Eslami, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Investigator'}, {'name': 'Ali asghar Akhlaghi, BS.c', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Investigator'}, {'name': 'Reza salmanyazdi, MLD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Investigator'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royan Institute', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}