Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-25 @ 1:59 PM
Study NCT ID:
NCT03589092
Status:
UNKNOWN
Last Update Posted:
2020-06-25
First Post:
2018-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Genetic Causes of Gestational Diabetes in the Emirati Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'C562772', 'term': 'Mason-Type Diabetes'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059014', 'term': 'High-Throughput Nucleotide Sequencing'}], 'ancestors': [{'id': 'D017421', 'term': 'Sequence Analysis'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'DNA will be extracted from collected blood samples for genetic analysis'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-24', 'studyFirstSubmitDate': '2018-07-02', 'studyFirstSubmitQcDate': '2018-07-16', 'lastUpdatePostDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GDM Identification', 'timeFrame': 'through study completion, an average of 2 year', 'description': "Identifying individuals with history of GDM or current diagnosis of GDM and analysing their GTT results and likelihood of MODY. GTT results will be extracted from patient's medical records."}], 'secondaryOutcomes': [{'measure': 'Next Generation Sequencing (NGS)', 'timeFrame': 'through study completion, an average of 2 year', 'description': 'Next Generation Sequencing (NGS) technology will be applied to perform genetic testing, analysing 13 previously published MODY genes and potentially identifying novel causative mutations.'}, {'measure': 'Novel diabetes genes', 'timeFrame': 'through study completion, an average of 2 year', 'description': 'Identifying novel diabetes genes in the Emirati women with GDM by performing whole exome sequencing.'}, {'measure': 'Genetic test results validation', 'timeFrame': 'through study completion, an average of 2 year', 'description': 'Validating positive genetic test results by performing mutational analysis on parental, siblings and relatives samples. Request from parents, siblings and/or relatives to participate in the study will only occur if a novel (potentially pathogenic mutation) is identified and the primary participant agrees to it.'}, {'measure': 'Potential biomarkers', 'timeFrame': 'through study completion, an average of 2 year', 'description': 'Identifying potential biomarkers in women with MODY and who are developing GDM, to assist the selection of women suitable for genetic screening.'}, {'measure': 'Prevalence of MODY', 'timeFrame': 'through study completion, an average of 2 year', 'description': 'Determining the prevalence of MODY in women with GDM in the UAE.'}, {'measure': 'Clinical outcomes determination', 'timeFrame': 'through study completion, an average of 2 year', 'description': 'Determining the short and the long-term clinical outcomes of MODY in women with GDM in the UAE'}]}, 'conditionsModule': {'keywords': ['GDM', 'MODY', 'Genetic testing', 'Next Generation Sequencing', 'NGS'], 'conditions': ['Gestational Diabetes', 'GDM', 'Maturity-onset Diabetes of the Young', 'MODY']}, 'descriptionModule': {'briefSummary': 'The study aims to identify the number of MODY patients to be found among Emirati women with GDM as the incidence and prevalence of monogenic diabetes among this group of patients is unknown. This will enable improvements in diagnostics, treatment and the counselling of these women.', 'detailedDescription': 'The present study aims to perform systematic genetic screening of genes known as the cause of MODY in women diagnosed with gestational diabetes to estimate the prevalence of MODY. This is important to understand the extent to which monogenic diabetes is encountered for the first time during pregnancy. Once women with MODY developing GDM have been identified, biomarkers to identify these women can be found which will assist the clinical process of performing genetic screening in the right subset of patients. Also for the women participating in the present study, this is of great importance as correct genetic diagnosis will provide them with the needed information to receive optimal treatment, correct plan for follow-up and a more accurate prognosis in relation to risk of future complication and therefore prevention of such.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women diagnosed with GDM, through Imperial College London Diabetes Centre (ICLDC) gestational diabetes clinic.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently pregnant women diagnosed with GDM.\n* Women with history of GDM (with negative GAD/IA2 antibodies if results available).\n\nExclusion Criteria:\n\n* Women with positive GAD/IA2 antibodies (if results available)\n* Women genetically diagnosed as MODY'}, 'identificationModule': {'nctId': 'NCT03589092', 'briefTitle': 'Genetic Causes of Gestational Diabetes in the Emirati Population', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London Diabetes Centre'}, 'officialTitle': 'Genetic Causes of Gestational Diabetes in the Emirati Population', 'orgStudyIdInfo': {'id': 'IREC032'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GDM Current', 'description': 'Currently pregnant women diagnosed with GDM.\n\nNext generation sequencing (NGS) methodologies will used on individuals suspected of genetic diabetes.', 'interventionNames': ['Genetic: Next generation sequencing (NGS)']}, {'label': 'GDM History', 'description': 'Women with history of GDM (with negative GAD/IA2 antibodies if results available).\n\nNext generation sequencing (NGS) methodologies will used on individuals suspected of genetic diabetes.', 'interventionNames': ['Genetic: Next generation sequencing (NGS)']}], 'interventions': [{'name': 'Next generation sequencing (NGS)', 'type': 'GENETIC', 'description': 'NGS Panel, Whole exome/genome sequencing', 'armGroupLabels': ['GDM Current', 'GDM History']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48338', 'city': 'Abu Dhabi', 'status': 'RECRUITING', 'country': 'United Arab Emirates', 'contacts': [{'name': 'Hinda Daggag, PhD', 'role': 'CONTACT', 'email': 'hdaggag@icldc.ae', 'phone': '+971 2 404 0800'}], 'facility': 'Imperial College London Diabetes Centre', 'geoPoint': {'lat': 24.45118, 'lon': 54.39696}}], 'centralContacts': [{'name': 'Hinda Daggag, PhD', 'role': 'CONTACT', 'email': 'hdaggag@icldc.ae', 'phone': '+971 2 404 0800'}], 'overallOfficials': [{'name': 'Maha Barakat, PhD FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London Diabetes Centre'}, {'name': 'Torben Hansen, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London Diabetes Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}