Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-01-01 @ 9:29 AM
Study NCT ID:
NCT02082132
Status:
UNKNOWN
Last Update Posted:
2020-08-04
First Post:
2013-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MODY in Young-onset Diabetes in Different Ethnicities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2022-10-10', 'unreleaseDate': '2022-10-14'}, {'resetDate': '2023-12-01', 'releaseDate': '2023-02-28'}, {'resetDate': '2024-05-10', 'releaseDate': '2023-12-01'}], 'estimatedResultsFirstSubmitDate': '2022-10-10'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': "We will be collecting blood and urine samples for routine diabetes tests as well as more specialist tests that will help define what type of diabetes is present. We'll also collect DNA to look for MODY (maturity onset diabetes of the young), the genetic cause of diabetes, in some people."}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 916}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-03', 'studyFirstSubmitDate': '2013-10-15', 'studyFirstSubmitQcDate': '2014-03-05', 'lastUpdatePostDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of MODY', 'timeFrame': '5 years', 'description': 'Comparison of frequency of MODY mutations between two ethnic groups'}], 'secondaryOutcomes': [{'measure': 'Comparison of biochemical and clinical characteristics in people with MODY between each ethnic group.', 'timeFrame': '5 years', 'description': '* Difference in fasting C-peptide levels between UK South Asian and white European people\n* Difference in BMI, waist and hip circumference between UK South Asian and white European people\n* Differences in affected gene between UK South Asian and white European people'}, {'measure': 'Comparison of clinical and biochemical characteristics of other subtypes of diabetes', 'timeFrame': '5 years', 'description': 'In people phenotyped as type 1 or type 2 diabetes:\n\n* Difference in fasting C-peptide levels between UK South Asian and white European people\n* Difference in BMI, waist and hip circumference between UK South Asian and white European people\n* Differences in diabetes antibody positivity between UK South Asian and white European people'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Maturity Onset Diabetes of the Young', 'Type 1 Diabetes', 'Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '20499044', 'type': 'BACKGROUND', 'citation': 'Shields BM, Hicks S, Shepherd MH, Colclough K, Hattersley AT, Ellard S. Maturity-onset diabetes of the young (MODY): how many cases are we missing? Diabetologia. 2010 Dec;53(12):2504-8. doi: 10.1007/s00125-010-1799-4. Epub 2010 May 25.'}, {'pmid': '18301398', 'type': 'BACKGROUND', 'citation': 'Murphy R, Ellard S, Hattersley AT. Clinical implications of a molecular genetic classification of monogenic beta-cell diabetes. Nat Clin Pract Endocrinol Metab. 2008 Apr;4(4):200-13. doi: 10.1038/ncpendmet0778. Epub 2008 Feb 26.'}, {'pmid': '17054605', 'type': 'BACKGROUND', 'citation': 'Porter JR, Rangasami JJ, Ellard S, Gloyn AL, Shields BM, Edwards J, Anderson JM, Shaw NJ, Hattersley AT, Frayling TM, Plunkett M, Barrett TG. Asian MODY: are we missing an important diagnosis? Diabet Med. 2006 Nov;23(11):1257-60. doi: 10.1111/j.1464-5491.2006.01958.x.'}, {'pmid': '22218698', 'type': 'BACKGROUND', 'citation': 'Shields BM, McDonald TJ, Ellard S, Campbell MJ, Hyde C, Hattersley AT. The development and validation of a clinical prediction model to determine the probability of MODY in patients with young-onset diabetes. Diabetologia. 2012 May;55(5):1265-72. doi: 10.1007/s00125-011-2418-8. Epub 2012 Jan 5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to describe and compare the different types of diabetes that exist in people from white European and south Asian origin in the UK (United Kingdom) who are diagnosed with diabetes before they turn 30 years old. By doing this we hope to identify cases of MODY (maturity onset diabetes of the young), which is a rare genetic cause of diabetes that is frequently misdiagnosed. Identifying MODY cases is important, as the treatment may differ to conventional treatment for type 1 or type 2 diabetes.', 'detailedDescription': 'People who meet the recruitment criteria, will be invited to attend for a single fasted 2 hour visit at our research facility. During the visit we will record details of their diabetes history as well as their general health and undertake blood and urine tests. At the end of the visit their participation will be complete. We will contact them later to discuss results of specialist blood tests and whether or not they have MODY, if they have had genetic testing performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'People in the UK diagnosed with any type of diabetes before the age of 30 years from either white European or South Asian origin.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosed with diabetes on the basis of fasting glucose and/or oral glucose tolerance test and/or HbA1c as per WHO criteria.\n* Diagnosed with diabetes between 6 months and 30 years of age.\n* South Asian ancestry- defined as self-reported ancestry and at least 2 grandparents from the Indian Subcontinent (India, Pakistan, Bangladesh or Sri Lanka).\n* European ancestry - defined as self-reported ancestry and at least 2 grandparents from within Europe.\n\nExclusion Criteria:\n\n* An established secondary cause of diabetes exists (for example recurrent pancreatitis, pancreatectomy, new onset diabetes after transplantation, Cushing's syndrome, acromegaly, steroid induced).\n* Enrolled in another study.\n* Have active malignancy or under investigation for malignancy."}, 'identificationModule': {'nctId': 'NCT02082132', 'acronym': 'MYDIABETES', 'briefTitle': 'MODY in Young-onset Diabetes in Different Ethnicities', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'A Cross-sectional Study of Young-onset Diabetes in Two UK Ethnic Groups.', 'orgStudyIdInfo': {'id': '13SM0659'}}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Shivani Misra, MBBS, MRCP', 'role': 'CONTACT', 'email': 's.misra@imperial.ac.uk', 'phone': '0207 594 2460'}, {'name': 'Shivani Misra, MBBS, MRCP', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Imperial College Clinical Research Facility', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Nick S Oliver, MRCP', 'role': 'CONTACT', 'email': 'nick.oliver@imperial.ac.uk', 'phone': '+442033311065'}, {'name': 'Des G Johnston, FRCP, PhD', 'role': 'CONTACT', 'email': 'd.johnston@imperial.ac.uk', 'phone': '+442075942429'}], 'overallOfficials': [{'name': 'Nick S Oliver, MBBS, MRCP', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Imperial College London'}, {'name': 'Shivani Misra, MBBS, MRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-10-10', 'type': 'RELEASE'}, {'date': '2022-10-14', 'type': 'UNRELEASE'}, {'date': '2023-02-28', 'type': 'RELEASE'}, {'date': '2023-12-01', 'type': 'RESET'}, {'date': '2023-12-01', 'type': 'RELEASE'}, {'date': '2024-05-10', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Imperial College London'}}}}