Ignite Creation Date:
2025-12-24 @ 1:16 PM
Ignite Modification Date:
2025-12-27 @ 10:00 PM
Study NCT ID:
NCT01307995
Status:
COMPLETED
Last Update Posted:
2011-03-03
First Post:
2011-03-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Incretin Effect in Patients With Gestational Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-02', 'studyFirstSubmitDate': '2011-03-02', 'studyFirstSubmitQcDate': '2011-03-02', 'lastUpdatePostDateStruct': {'date': '2011-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['GDM', 'incretin effect', 'gestation', 'reversibility'], 'conditions': ['Gestational Diabetes']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the reduced incretin effect observed in patients with T2DM in relation to reversibility. The incretin effect will be measured by means of OGTT and iIVGTT in 12 women with GDM during pregnancy (third trimester), and again 2-3 months post partum. It is anticipated that the incretin effect in patients with GDM is reduced - like in patients with other forms of DM. The investigators estimate that approximately 90 % of the patients with GDM re-establish a NGT 2-3 months post partum. This particular group of patients provides a unique possibility for demonstrating the reversibility of the reduced incretin effect in relation to optimal glycaemic control.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women above the age of 18 years with GDM) (Controls: pregnant women above the age of 18 years with NGT)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age above 18 years old\n* GDM diagnosed according to WHO guidelines (GDM group) or ruled out by OGTT 75g (Control group)\n\nExclusion Criteria:\n\n* Previous diagnosis of DM\n* Positive GAD-65-autoantibodies and/or positive islet cell autoantibodies (ICA)\n* Affected biochemical liver parameters (ALAT \\> 2 times normal upper range)\n* Affected biochemical kidney parameters (se-creatinine \\> 130 µM)\n* Treatment with medicine interacting with insulin secretion (e.g. steroids)\n* Treatment with medicine that can not be paused for 16 hours'}, 'identificationModule': {'nctId': 'NCT01307995', 'briefTitle': 'The Incretin Effect in Patients With Gestational Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Lodz'}, 'officialTitle': 'Observational Study to Evaluate the Reduced Incretin Effect Observed in Patients With GDM in Relation to Reversibility After a Delivery.', 'orgStudyIdInfo': {'id': 'GDM-INK'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GDM', 'description': 'Patients with Gestational Diabetes Mellitus found during pregnancy by means of 75g OGTT'}, {'label': 'NGT', 'description': 'Pregnant patients with normal glucose tolerance as observed in 75g OGTT'}]}, 'contactsLocationsModule': {'locations': [{'zip': '93-338', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Departament of Diabetology and Metabolic Diseases, Polish Mothers Research Hospital', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}], 'overallOfficials': [{'name': 'Katarzyna Cypryk, MD, PhD, Asoc. Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical University Lodz'}, {'name': 'Tina Vilsbøll, MD, DMSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Copenhagen'}, {'name': 'Marcin Kosiński, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University Lodz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Lodz', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Marcin Kosinski', 'oldOrganization': 'Diabetology and Metabolic Diseases Departament'}}}}