UK Children's Diabetes Research
Although diabetes is a nuisance, it does not need to interfere with your life (you can even win a gold medal for rowing at the Olympics!), but you need to keep the blood sugars in the normal range to prevent problems developing in the future. A small number of young people with diabetes will develop problems with their kidneys and eyes when they become adults. Although nowadays these problems or "complications" as they are called, can be treated it would be much better if we could predict which people are going to have problems and try and prevent them as soon as possible.
The risk of developing complications may be partly due to the genes inherited from parents. Just the same as these genes determine the colour of our eyes and the colour of our hair, they may also determine the risk of people with diabetes developing complications. To find these genes, firstly we need a sample of your blood, and secondly we need to know how your kidneys are coping with the diabetes. Small leaks of protein in the urine and changes in blood pressure may be early signs of the risk of complications. We want to study these markers in you and your parents.
Many of you will already be having an annual assessment or an MOT test which involves checking your height and weight, getting urine samples to look for small amounts of protein and taking a blood sample for the long term measurement of sugar levels or HbA1c.
If you join the study, the only difference would be that there would be a research nurse who helps your doctor get these assessments and the tests that you have will be the same as those that we obtain from 1,000 other children around the country. As before, the results of the tests will be fed back to your doctor so that he or she can decide whether you need to change your treatment.
The only possible difference between these annual assessments and the ones that you have been having before is that we will need to get the blood sample from a vein. As you know, blood sampling can cause some discomfort, but this is usually minimal with the use of EMLA cream, a local anaesthetic cream that numbs the skin.
The other additional thing is that we would want to check your blood pressure over 24hours using a simple automatic blood pressure recorder which can be worn at weekends or even during a day at school. The recorder is the size and weight of a Walkman personal stereo and you will still be able to do most of your normal activities while wearing it. The blood pressure test is similar to those taken in clinic. The recorder will be set to take a recording at half hourly intervals and it can be uncomfortable, particularly at night. If you were to find it uncomfortable, or a problem, you could stop the test. However, generally most people find it fun, particularly during the day. You will be provided with a blood pressure advice and diary sheet. It sounds rather complicated but the research nurse will show you how to use the machine and record all your days activities.
Finally, for a change, we will also be asking your parents to give up a blood sample, collect urines and have their blood pressures checked.
The study is being co-ordinated from Cambridge and that is where all the bloods and urines will be sent. Your samples and any information you give us will be attached to your own personal study number. Your nurse and consultant will make all the arrangements and the laboratory in Cambridge will not be given your name and address.
The results of each year's blood and urine tests will be passed back to your doctor and nurse so that they can decide whether you need any change in treatment. It is likely that we will need to go on collecting information for 3 or 4 years and we will let you know if things have changed over that period.
We will promise to keep you informed of the progress of the study of the genes, but we will not be able to tell you, your parents, or your consultant, about your own particular test result as all the analysis will be done without knowing the identity of any of the individuals taking part.
We always try to ensure that both you and your parents are happy to participate in the study. If you and your parents disagree, we would ask you to take the information sheet home for a few more days and think it over. If after discussing it with your parents you still cannot agree, we would do whatever you want, as at the age of 16 years, you can make your own decision. If you really wanted to join the study, you would be asked to sign a consent form. If you decided not to participate, that is fine and will not affect your clinic visits in any way.
Your doctor and the research nurse will arrange dates for your annual assessment. This could coincide with the annual assessments you have been having already, or we may set it up in a special clinic. On the same day, or at another time the nurse will arrange for you to wear the blood pressure monitor, and she will also arrange to see your parents to get their "specimens".
We would reimburse you and your parents for any travel expenses or loss of earnings, but you will need to keep the receipts.
If at a later date you decide you don't want to go on with the study, just tell your doctor or study nurse. If it was your wish, we would destroy the blood and DNA samples you had already given.
If you want to ask questions or require further information, please get in touch with your doctor [doctor] or your nurse in the clinic [clinic].
If you'd rather, you could email the investigators in Cambridge at the following dedicated email address:
ukgrid@paed.cam.ac.uk
| UK Children's Diabetes Research file: | http://www.childhood-diabetes.org.uk/info/neph-info-16-18.shtml |
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| Written by: | Neil Walker |
| Last modified: | 17/07/2007 |