Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-01-07 @ 7:54 PM
Study NCT ID:
NCT00681460
Status:
COMPLETED
Last Update Posted:
2015-05-27
First Post:
2008-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metformin in Gestational Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D001724', 'term': 'Birth Weight'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-23', 'studyFirstSubmitDate': '2008-05-19', 'studyFirstSubmitQcDate': '2008-05-20', 'lastUpdatePostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'newborn weight', 'timeFrame': 'first hour of life'}], 'secondaryOutcomes': [{'measure': 'parameters of metabolic control in mother and newborn, insulin resistance, inflammatory reaction, oxidative stress, fetal growth,', 'timeFrame': 'during pregnancy and up to twelve hours after delivery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['gestational diabetes', 'birth weight', 'fetal growth', 'insulin resistance', 'oxidative stress', 'inflammatory reaction', 'Fetal Development'], 'conditions': ['Diabetes, Gestational', 'Insulin Resistance']}, 'descriptionModule': {'briefSummary': "Gestational diabetes (GDM) is a condition that manifests as high blood sugar levels (hyperglycemia) during pregnancy in previously healthy women. It develops as a result of increased maternal body's resistance to insulin - a major hormone that allows for utilisation of glucose (sugar taken in with food) within cells. It was found out that GDM occurs more frequently in overweight women but also in women with a history of certain conditions such as polycystic ovary syndrome (PCOS). Usually, GDM disappears after pregnancy is completed but it is associated with some serious hazards for women and her unborn child, if untreated properly. Diet is a first-choice treatment but sometimes insulin therapy must be initiated if keeping a diet alone is not enough to maintain blood sugar within recommended values. Insulin therapy is effective but it requires several injections during each day and insulin is a strong acting hypoglycemic agent that may induce rapid falls in blood sugar, also dangerous for mother and unborn child.\n\nIn the investigators study, the investigators would like to investigate if metformin that is a commonly used hypoglycemic drug can be effectively used for GDM treatment. Metformin has been used successfully for a long time to treat type 2 diabetes mellitus and PCOS and, according to current data, it is not dangerous neither for mother nor for baby when used during gestation."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diabetes diagnosed during pregnancy\n* single pregnancy\n* ineffective diet therapy\n\nExclusion Criteria:\n\n* pregestational diabetes\n* fetal malformation\n* multiple pregnancy\n* contraindications to metformin therapy (liver or kidney disease)'}, 'identificationModule': {'nctId': 'NCT00681460', 'acronym': 'MetGDM', 'briefTitle': 'Metformin in Gestational Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'K. Marcinkowski University of Medical Sciences'}, 'officialTitle': 'Effects of Insulin and/or Metformin Treatment on Perinatal Outcome and Metabolic Parameters in Women With Gestational Diabetes Mellitus: Prospective Randomized Trial.', 'orgStudyIdInfo': {'id': 'KMUMS 705/07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'gestational diabetes, insulin therapy', 'interventionNames': ['Drug: human recombined insulin']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'gestational diabetes, metformin therapy', 'interventionNames': ['Drug: metformin']}], 'interventions': [{'name': 'human recombined insulin', 'type': 'DRUG', 'description': 'multiple injections protocol (functional intensive insulin therapy), variable doses following dietary conditions and current metabolic status', 'armGroupLabels': ['1']}, {'name': 'metformin', 'type': 'DRUG', 'description': 'pills given orally twice up to three times a day, a total daily dosage 1000-2400 mg', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60-535', 'city': 'Poznan', 'country': 'Poland', 'facility': "Div of Obstetrics and Women's Diseases, Dept of Obstetrics and Gynecology, K Marcinkowski Univ of Med Sciences", 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}], 'overallOfficials': [{'name': 'Jacek Brazert, MD.PhD.prof', 'role': 'STUDY_CHAIR', 'affiliation': 'K Marcinkowski University of Med Sciences, Poznan, Poland'}, {'name': 'Antoni J Duleba, MD.prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of California at Davis, Sacramento, CA, USA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'K. Marcinkowski University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Department of Obstetrics and Women's Diseases, Senior Lecturer", 'investigatorFullName': 'Agnieszka Zawiejska, MD, PhD', 'investigatorAffiliation': 'K. Marcinkowski University of Medical Sciences'}}}}