NCT02082132

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
916

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2013

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 10, 2014

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

August 4, 2020

Status Verified

August 1, 2020

Enrollment Period

7.7 years

First QC Date

October 15, 2013

Last Update Submit

August 3, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Frequency of MODY

    Comparison of frequency of MODY mutations between two ethnic groups

    5 years

Secondary Outcomes (2)

  • Comparison of biochemical and clinical characteristics in people with MODY between each ethnic group.

    5 years

  • Comparison of clinical and biochemical characteristics of other subtypes of diabetes

    5 years

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College Clinical Research Facility

London, United Kingdom

RECRUITING

Related Publications (4)

  • 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.

    PMID: 20499044BACKGROUND
  • 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.

    PMID: 18301398BACKGROUND
  • 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.

    PMID: 17054605BACKGROUND
  • 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.

    PMID: 22218698BACKGROUND

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.

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Nick S Oliver, MBBS, MRCP

    Imperial College London

    STUDY DIRECTOR
  • Shivani Misra, MBBS, MRCP

    Imperial College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nick S Oliver, MRCP

CONTACT

Des G Johnston, FRCP, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2013

First Posted

March 10, 2014

Study Start

October 1, 2013

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

August 4, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations