MODY in Young-onset Diabetes in Different Ethnicities

Diabetes Clinical Trial

— MYDIABETES  

Official title:

A Cross-sectional Study of Young-onset Diabetes in Two UK Ethnic Groups.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02082132
• Other study ID #: 13SM0659
• Status: Recruiting
• Start date: October 2013
• Est. completion date: June 2021

Study information

• Verified date: August 2020
• Source: Imperial College London
• Contact: Nick S Oliver, MRCP
• Phone: +442033311065
• Email: nick.oliver[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 916
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Maturity Onset Diabetes of the Young
• Type 1 Diabetes
• Type 2 Diabetes

Locations

Country	Name	City	State
United Kingdom	Imperial College Clinical Research Facility	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

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. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of MODY	Comparison of frequency of MODY mutations between two ethnic groups	5 years
Secondary	Comparison of biochemical and clinical characteristics in people with MODY between each ethnic group.	Difference in fasting C-peptide levels between UK South Asian and white European people; Difference in BMI, waist and hip circumference between UK South Asian and white European people; Differences in affected gene between UK South Asian and white European people	5 years
Secondary	Comparison of clinical and biochemical characteristics of other subtypes of diabetes	In people phenotyped as type 1 or type 2 diabetes: Difference in fasting C-peptide levels between UK South Asian and white European people; Difference in BMI, waist and hip circumference between UK South Asian and white European people; Differences in diabetes antibody positivity between UK South Asian and white European people	5 years