MODY in Young-onset Diabetes in Different Ethnicities
MYDIABETES
A Cross-sectional Study of Young-onset Diabetes in Two UK Ethnic Groups.
1 other identifier
observational
916
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 15, 2013
CompletedFirst Posted
Study publicly available on registry
March 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedAugust 4, 2020
August 1, 2020
7.7 years
October 15, 2013
August 3, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Frequency of MODY
Comparison of frequency of MODY mutations between two ethnic groups
5 years
Secondary Outcomes (2)
Comparison of biochemical and clinical characteristics in people with MODY between each ethnic group.
5 years
Comparison of clinical and biochemical characteristics of other subtypes of diabetes
5 years
Eligibility Criteria
People in the UK diagnosed with any type of diabetes before the age of 30 years from either white European or South Asian origin.
You may qualify if:
- Diagnosed with diabetes on the basis of fasting glucose and/or oral glucose tolerance test and/or HbA1c as per WHO criteria.
- Diagnosed with diabetes between 6 months and 30 years of age.
- South Asian ancestry- defined as self-reported ancestry and at least 2 grandparents from the Indian Subcontinent (India, Pakistan, Bangladesh or Sri Lanka).
- European ancestry - defined as self-reported ancestry and at least 2 grandparents from within Europe.
You may not qualify if:
- An established secondary cause of diabetes exists (for example recurrent pancreatitis, pancreatectomy, new onset diabetes after transplantation, Cushing's syndrome, acromegaly, steroid induced).
- Enrolled in another study.
- Have active malignancy or under investigation for malignancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Imperial College Clinical Research Facility
London, United Kingdom
Related Publications (4)
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: 20499044BACKGROUNDMurphy 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: 18301398BACKGROUNDPorter 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: 17054605BACKGROUNDShields 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.
PMID: 22218698BACKGROUND
Biospecimen
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.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nick S Oliver, MBBS, MRCP
Imperial College London
- PRINCIPAL INVESTIGATOR
Shivani Misra, MBBS, MRCP
Imperial College London
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2013
First Posted
March 10, 2014
Study Start
October 1, 2013
Primary Completion
June 1, 2021
Study Completion
June 1, 2021
Last Updated
August 4, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share