MODY in Young-onset Diabetes in Different Ethnicities

NCT ID: NCT02082132

Last Updated: 2020-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

916 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2021-06-30

Brief Summary

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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

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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.

Conditions

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Diabetes Maturity Onset Diabetes of the Young Type 1 Diabetes Type 2 Diabetes

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nick S Oliver, MBBS, MRCP

Role: STUDY_DIRECTOR

Imperial College London

Shivani Misra, MBBS, MRCP

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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Imperial College Clinical Research Facility

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Nick S Oliver, MRCP

Role: CONTACT

+442033311065

Des G Johnston, FRCP, PhD

Role: CONTACT

+442075942429

Facility Contacts

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Shivani Misra, MBBS, MRCP

Role: primary

0207 594 2460

References

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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.

Reference Type BACKGROUND
PMID: 20499044 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18301398 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17054605 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22218698 (View on PubMed)

Other Identifiers

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13SM0659

Identifier Type: -

Identifier Source: org_study_id

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