DiabetesMYDIABETESNCT02082132
MODY in Young-onset Diabetes in Different Ethnicities
An observational study of Diabetes and Maturity Onset Diabetes of the Young, run by Imperial College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Diabetes, Maturity Onset Diabetes of the Young, Type 1 Diabetes
- How many people
- 916 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2013to Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College Clinical Research Facility
London
Shivani Misra, MBBS, MRCP, 0207 594 2460, s.misra@imperial.ac.uk
Shivani Misra, MBBS, MRCP
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of MODY
Comparison of frequency of MODY mutations between two ethnic groups
Measured: 5 years
Secondary outcomes (2)
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
Measured: 5 years
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2014 (estimated)
- Study startOct 2013
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 916 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nick S Oliver, MBBS, MRCP, Study director, Imperial College LondonShivani Misra, MBBS, MRCP, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02082132
- Sponsor's protocol ID
- 13SM0659
- Acronym
- MYDIABETES
- Status last verified
- Aug 2020
- First submitted
- 15 Oct 2013
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 20499044Murphy 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.
PubMed 18301398Porter 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.
PubMed 17054605Shields 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.
PubMed 22218698
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Study of Young-onset Diabetes in Two UK Ethnic Groups.
- ClinicalTrials.gov ID
- NCT02082132
- Acronym / sponsor ID
- MYDIABETES / 13SM0659
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 916 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 10 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of MODY
Time frame: 5 years
Comparison of frequency of MODY mutations between two ethnic groups
2 secondary outcomes
Comparison of biochemical and clinical characteristics in people with MODY between each ethnic group.
Time frame: 5 years
Comparison of clinical and biochemical characteristics of other subtypes of diabetes
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
- Background: PubMed 20499044Shields 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.
- Background: PubMed 18301398Murphy 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.
- Background: PubMed 17054605Porter 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.
- Background: PubMed 22218698Shields 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nick S Oliver, MBBS, MRCP study director
Imperial College London
Shivani Misra, MBBS, MRCP principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Maturity Onset Diabetes of the Young, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nick S Oliver, MRCP (+442033311065, nick.oliver@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of MODY (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02082132, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2020.