Clinical trial NCT02082132: MODY in Young-onset Diabetes in Different Ethnicities
Official title: A Cross-sectional Study of Young-onset Diabetes in Two UK Ethnic Groups.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes
Maturity Onset Diabetes of the Young
Type 1 Diabetes
Type 2 Diabetes
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2014-03-10
Enrollment: 916
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: People in the UK diagnosed with any type of diabetes before the age of 30 years from either white European or South Asian origin.

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Frequency of MODY
timeFrame: 5 years
Secondary outcomes:
measure: Comparison of biochemical and clinical characteristics in people with MODY between each ethnic group.
timeFrame: 5 years
measure: Comparison of clinical and biochemical characteristics of other subtypes of diabetes
timeFrame: 5 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Clinical Research Facility
Study officials:
affiliation: Imperial College London
name: Nick S Oliver, MBBS, MRCP
role: STUDY_DIRECTOR
affiliation: Imperial College London
name: Shivani Misra, MBBS, MRCP
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.