Institution
University of Cambridge.
Name of lead investigator
Professor David Dunger, Professor of Paediatrics.
Research funded by
Diabetes UK, Juvenile Diabetes Research Foundation, British Heart Foundation.
Who to contact
To register to take part in the study, please email the study nurse in your area:
Aylesbury & High Wycombe
Pamela.harris@buckshealthcare.nhs.uk
Birmingham
LYDIAH.Makusha@bch.nhs.uk
Bristol
Pippa.taylor@bristol.ac.uk
Helen.Pluess-hall@bristol.ac.uk
Bolton
Claire.fish@cmft.nhs.uk
Cambridge
ja453@medschl.cam.ac.uk
Ipswich
Jon.hassler-hurst@ipswichhospital.nhs.uk
Leeds
Jane.exall@leedsth.nhs.uk
Manchester
jessica.nichols@cmft.nhs.uk
Middlesbrough
alison.murray@stees.nhs.uk
Newcastle
Phil.woodsford@nuth.nhs.uk
Evelyn.thomson@nuth.nhs.uk
Northampton
Jennifer.spimpolo@ngh.nhs.uk
lucy.dudgeon@ngh.nhs.uk
Norwich
Louisa.fear@nnuh.nhs.uk
Oxford
Jane.bowen-morris@ouh.nhs.uk
Clare.megson@ouh.nhs.uk
Reading
Clare.megson@ouh.nhs.uk
Stockport
Sara.bennett@stockport.nhs.uk
West Suffolk
Jo.bytham@nhs.net
Wigan
Jane.howell@cmft.nhs.uk
Recruiting until
June 2013
Total number of participants needed
3,000, of which 500 will be asked to join a randomised controlled trial and 400 will be asked to join an observation study.
Who can and cannot take part?
Inclusion criteria
Children aged 10-16 who were diagnosed with Type 1 diabetes at least a year ago and who live near Birmingham, Cambridge, Oxford, Bristol, Manchester, Newcastle, Aylesbury, High Wycombe, Bolton, Northampton, Norwich, Stockport, Wigan or Leeds.
Exclusion criteria
- People without Type 1 diabetes (e.g. people with Type 2 diabetes or secondary diabetes)
- People who are pregnant or are unwilling to comply with contraceptive advice and regular pregnancy testing throughout the trial
- People who are breast feeding
- People with severe hyperlipidaemia and family history data to support diagnosis of familial hypercholesterolaemia
- People with established hypertension that is not associated with diabetes related kidney disease
- Those taking steroids or other medications which may effect renal function and interfere with the study
- People who have been exposed to statins or ACE inhibitors in the past
- Unwillingness/inability to comply with the study guidelines
- People with proliferative retinopathy
- People with kidney disease not associated with Type 1 diabetes.
About the research
What is the research about?
Although the complications associated with Type 1 diabetes are rarely seen during childhood, children and teenagers with the condition may find it difficult to achieve good blood glucose control and this may increase their risk of developing kidney, heart and circulatory disease as adults.
If particular proteins (known as albumins) are found in the urine of children with Type 1 diabetes, this may provide early evidence of diabetes-related heart and kidney disease.
In adults, these symptoms are often treated with particular drugs (known as ACE inhibitors and statins) that reduce blood pressure and blood fats, but it is unknown whether these drugs would also be effective in adolescents.
This study aims to determine the safety and effectiveness of these drugs in children and teenagers and will involve screening the urine of 3,000 children from the UK, Australia and Canada who are aged from 10-16 and have Type 1 diabetes.
Using urine samples, researchers will identify children who are producing high levels of albumins and may therefore be at an increased risk of diabetes-related complications.
500 of these children will be invited to participate in a randomised controlled trial to compare the effects of ACE inhibitors, statins, or combination therapy against a placebo. 400 children producing low levels of albumins will be asked to undergo observational assessments.
How will the research benefit people affected by Type 1 diabetes?
The findings of the study will provide important information on whether it is safe and effective to treat young people with statins and ACE inhibitors. This information will affect the future licensing and use of these drugs and could help to improve the prevention of heart and kidney disease among children and teenagers with Type 1 diabetes.
What will taking part in the research involve for participants and what are the risks?
Parents who live in the areas listed above are being asked to register their children with a local research centre so that they can donate urine samples that will be screened for albumins. Children may then be invited to join either the drug trial or the observation study.
Those who join the drug trial will be randomised to receive ACE inhibitors, statins, a combination of both or a placebo for at least three years. Over the course of the study, these participants will be seen every three months by study doctors for basic assessments and they will be asked to provide blood and urine samples every six months. Those in the observational study will undergo similar assessments but will not receive the study medications.
There are few risks to taking part, but there may be slight bruising as a result of the blood tests and some side effects from the study drugs, such as dizziness or a cough. A very small number of people experience headaches, fatigue, nausea, indigestion or muscle pain, but these side effects are very rare and it is very unlikely that someone would experience all of them.
Is there any compensation for taking part?
Travel expenses will be reimbursed for non-routine visits to the clinic.