MODY in Young-onset Diabetes in Different Ethnicities (MYDIABETES)

August 3, 2020 updated by: Imperial College London

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

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

916

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • Imperial College Clinical Research Facility
        • Principal Investigator:
          • Shivani Misra, MBBS, MRCP
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of MODY
Time Frame: 5 years
Comparison of frequency of MODY mutations between two ethnic groups
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of biochemical and clinical characteristics in people with MODY between each ethnic group.
Time Frame: 5 years
  • 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
Comparison of clinical and biochemical characteristics of other subtypes of diabetes
Time Frame: 5 years

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Investigators

  • Study Director: Nick S Oliver, MBBS, MRCP, Imperial College London
  • Principal Investigator: Shivani Misra, MBBS, MRCP, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2013

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

October 15, 2013

First Submitted That Met QC Criteria

March 5, 2014

First Posted (Estimate)

March 10, 2014

Study Record Updates

Last Update Posted (Actual)

August 4, 2020

Last Update Submitted That Met QC Criteria

August 3, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13SM0659

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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