Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT05932251
Status:
SUSPENDED
Last Update Posted:
2025-08-19
First Post:
2023-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Towards Precision Medicine for Diabetes in Pregnancy
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': 'D009043', 'term': 'Motor Activity'}], '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': 'D001519', 'term': 'Behavior'}]}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 103}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Poor recruitment efficacy', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2023-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2023-06-27', 'studyFirstSubmitQcDate': '2023-06-27', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'glucose-disposition-index', 'timeFrame': '35-37 weeks gestation', 'description': 'glucose-disposition-index is calculated as product of Stumvoll- and Matsuda-index, assessed during a 75g-oral glucose tolerance test,'}], 'secondaryOutcomes': [{'measure': 'Insulin treatment', 'timeFrame': '35-37 weeks gestation', 'description': 'requirement for additional insulin treatment'}, {'measure': 'HbA1c', 'timeFrame': '24-28 and 35-37 weeks gestation', 'description': 'HbA1c concentration'}, {'measure': 'Body weight', 'timeFrame': '24-28 and 35-37 weeks gestation', 'description': 'Fasting body weight, kg'}, {'measure': 'Body fat mass', 'timeFrame': '24-28 and 35-37 weeks gestation', 'description': 'Fasting body fat mass, in kg'}, {'measure': 'Physical Activity', 'timeFrame': '24-28 and 35-37 weeks gestation', 'description': 'Average steps per day, measured over 7-day period using accelerometry'}, {'measure': 'Dietary intake', 'timeFrame': '24-28 and 35-37 weeks gestation', 'description': 'Average energy intake, measured over 7 days using online dietary records'}, {'measure': 'Glucose control', 'timeFrame': '24-28 and 35-37 weeks gestation', 'description': 'Time in range (3-10 mol/l), measured over 7 days using continuous glucose monitors'}, {'measure': 'Delivery complications', 'timeFrame': 'Birth', 'description': 'occurence and type of complications during delivery'}, {'measure': 'Neonatal body weight', 'timeFrame': 'at birth, and at 6 weeks of age', 'description': 'Neonatal body weight'}, {'measure': 'Neonatal body length', 'timeFrame': 'at birth, and at 6 weeks of age', 'description': 'Neonatal body length'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['insulin sensitivity', 'insulin secretion', 'continuous glucose monitoring', 'metformin', 'physical activity'], 'conditions': ['Gestational Diabetes', 'Gestational Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Rationale: Gestational diabetes is currently treated by the one-size-fits-all-approach. Treatment efficacy is poorly defined and inconsiderate of patients clinical presentation Objective: To characterize the efficacy of pharmacological treatment of gestational diabetes mellitus between patients with distinct metabolic phenotypes Study design: Prospective observational study, in metformin-treatment efficacy is compared between patients with GDM caused by insulin resistance and patients with GDM caused by low insulin secretion.\n\nStudy population: A prospective cohort of 103 women with diagnosed gestational diabetes mellitus treated by metformin.\n\nMain study parameters/endpoints: Primary outcomes is the glucose-disposition-index in late pregnancy (35-37 weeks gestation) and requirement for supplemental insulin-treatment. Secondary outcomes include insulin sensitivity (Matsuda-index), insulin secretion (Stumvoll-index), HbA1c, gestational weight gain, body composition, physical activity, eating behavior, plasma biomarkers, glucose control, and maternal and infant pregnancy outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients, who are screened (selection per EXPECT-calculator risk for GDM \\>3.5% \\[26\\]) and diagnosed with GDM and treated with metformin are eligible. Per current clinical practice (IADPSG/WHO2013), GDM will be diagnosed at 24-28 weeks by a 75g-oral glucose-tolerance-test (OGTT), if plasma glucose concentrations are: fasting \\>5.1 mmol/L; 1-h \\>10 mmol/L; or 2-h \\>8.5 mmol/L.\\[2, 25\\] Metformin-treatment is initiated, if plasma glucose concentrations during the OGTT are: fasting \\>5.3 mmol/L; and postprandial: \\>7.8 mmol/L.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* having a confirmed single, viable pregnancy past 20 weeks gestation.\n* assigned to pharmacological (ie metformin) treatment for GDM.\n\nExclusion Criteria:\n\n* pre-existing diabetes, hypertension (SBP \\>160 mmHg \\& DBP \\>110 mmHg)\n* using medication related to study outcomes prior to GDM diagnosis (insulin, metformin, glyburide, systemic steroids, mood stabilizers, ADHD medication)\n* smoking or using recreational drugs that may affect pregnancy outcomes'}, 'identificationModule': {'nctId': 'NCT05932251', 'acronym': 'ToPMedDiP', 'briefTitle': 'Towards Precision Medicine for Diabetes in Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Zuyderland Medisch Centrum'}, 'officialTitle': 'Towards Precision Medicine for Diabetes in Pregnancy', 'orgStudyIdInfo': {'id': 'NL80773.096.22'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Low insulin sensitivity', 'description': 'Women will be classified as having low insulin sensitivity, if their Matsuda-index is in the lowest quartile of a reference cohort', 'interventionNames': ['Drug: Metformin']}, {'label': 'Low insulin secretion', 'description': 'Women will be classified as having low insulin secretion if their Stumvoll-index is in the lowest quartile of a reference cohort', 'interventionNames': ['Drug: Metformin']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'description': 'All patients are diagnosed with gestational diabetes and treated with metformin (per routine clinical practice', 'armGroupLabels': ['Low insulin secretion', 'Low insulin sensitivity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6419PC', 'city': 'Heerlen', 'country': 'Netherlands', 'facility': 'Zuyderland Medisch Centrum', 'geoPoint': {'lat': 50.88365, 'lon': 5.98154}}], 'overallOfficials': [{'name': 'Jasper Most, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zuyderland Medisch Centrum'}, {'name': 'Jonas Ellerbrock, MD, PhDc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zuyderland Medisch Centrum'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'IPD may be shared with investigators upon reasonable, detailed and written request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zuyderland Medisch Centrum', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}