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

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ClinicalTrials.gov Identifier: NCT02082132
Recruitment Status : Recruiting
First Posted : March 10, 2014
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Imperial College London

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.

Condition or disease
Diabetes Maturity Onset Diabetes of the Young Type 1 Diabetes 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.

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Study Type : Observational
Estimated Enrollment : 916 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: A Cross-sectional Study of Young-onset Diabetes in Two UK Ethnic Groups.
Actual Study Start Date : October 2013
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021





Primary Outcome Measures :
  1. Frequency of MODY [ Time Frame: 5 years ]
    Comparison of frequency of MODY mutations between two ethnic groups


Secondary Outcome Measures :
  1. 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

  2. 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


Biospecimen Retention:   Samples With DNA
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.


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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082132


Contacts
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Contact: Nick S Oliver, MRCP +442033311065 nick.oliver@imperial.ac.uk
Contact: Des G Johnston, FRCP, PhD +442075942429 d.johnston@imperial.ac.uk

Locations
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United Kingdom
Imperial College Clinical Research Facility Recruiting
London, United Kingdom
Contact: Shivani Misra, MBBS, MRCP    0207 594 2460    s.misra@imperial.ac.uk   
Principal Investigator: Shivani Misra, MBBS, MRCP         
Sponsors and Collaborators
Imperial College London
Investigators
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Study Director: Nick S Oliver, MBBS, MRCP Imperial College London
Principal Investigator: Shivani Misra, MBBS, MRCP Imperial College London
Publications:
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02082132    
Other Study ID Numbers: 13SM0659
First Posted: March 10, 2014    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases