UK Children's Diabetes Research
The risk of serious diabetic complications has been much reduced by recent improvements in achieving good control of blood glucose in children with diabetes. However, a few children will still develop problems with their kidneys and eyes when they become adults. As well as being related to blood glucose levels, the risk of complications may be partly inherited. Some of the genes, which determine the colour of our eyes and hair etc, may also determine the risk of developing complications. These genes in the children may be related to the risk of high blood pressure or high blood fats in their parents.
Small leaks of protein in the urine of children and adolescents with diabetes (microalbuminuria) may be the first marker of the later risk for complications. We plan to investigate the relationship between protein in the urine of children with diabetes and blood pressure, blood fats and urinary protein excretion in their parents. We will also study the genes in the parents and the children to see if they explain these relationships.
The children and adolescents recruited for the study will be seen each year for 3 years. These visits, by a research nurse will be very much like the annual assessments that are already being done in the clinic. They will include measurements of height, weight, assessment of puberty and review of diabetes care over the previous year. A blood sample will be taken for measurement of HbA1c (which assesses blood glucose over the previous 3 months) and blood fats. A sample will also be retained for genetic studies. The total amount of blood taken each year will be 5-10ml (1-2 teaspoons). Blood sampling can cause some discomfort but this is usually minimal with the use of EMLA cream, a local anaesthetic that numbs the skin. Each 6 months we will also ask your child to provide 3 early morning urines for measurement of urinary protein excretion.
Your child's blood pressure will also be assessed over 24 hours using a simple automatic blood pressure recorder which can be worn at the weekends or even during a day at school (this is the size and weight of a Walkman personal stereo). Participants will receive instructions prior to the fitting of the monitor and will be able to carry out routine normal activities with the exception of driving (when the monitor should be switched off). The discomfort associated with the blood pressure measurement is similar to the blood pressure test taken routinely in clinic. The recorder will be set to take a recording at half hourly intervals and the participants will be provided with a blood pressure advice and diary sheet. The research nurse will show you how to use the machine and record the day's activity.
You, the parents, will only be asked to contribute a single blood sample for blood lipids and genetic studies (10-15ml or 2-3 teaspoons). We would also like you to wear a blood pressure monitor for 24hours and collect 3 early morning urine samples for measurement of protein excretion.
All of the blood and urine samples will be analysed at laboratories in Cambridge and Guy's hospital, London. Samples and questionnaires will be labelled with your unique study number and a number representing your hospital. Your nurse and consultant will make all the arrangements and the laboratory in Cambridge will not be given your name and address. Thus your confidentiality will be maintained.
We will feed back to your child's consultant the results of the blood and urine tests so that he/she can decide whether any change in treatment is needed. We will promise to keep you informed of the progress of the genetic studies, but we will not be able to tell you or your consultant about your own child's results as the analysis will be anonymous.
In the unlikely event that your own blood pressure or blood fat levels were increased, we would let you know and seek your permission to contact your GP so that he/she can advise on the need for further tests.
Your child's and your own DNA will only be analysed for genes relating to type 1 diabetes or its complications and will only be made available to scientists studying these conditions.
The DNA will not be used for any "genetic tests" as defined by insurance companies.
It is always possible that out of 1,500 samples we wish to collect, it might be possible to identify a gene for the potential treatment of diabetes or its complications. Such a discovery would not arise out of analysis of any individual sample, but rather out of analysis of all of the blood samples.
Ultimately if our aim is to prevent diabetes and its complications, information may be provided to pharmaceutical companies who would be the ones to develop new drugs. Often at this stage a pharmaceutical company may provide financial assistance to the research and in return would acquire the commercial rights to benefits arising from discoveries.
To allow collaborations to proceed, you are asked to waive any future claim to financial benefit through participation in the study. In reality, no single individual sample has any commercial value. We intend that:
We will always try and ensure that both you and your child are happy with all parts of the study. If after hearing all the information you do not agree with your child's choice, we might ask another diabetes doctor who is not involved with this study to speak to your child. If that doctor feels your child fully understands the reasons for entering or not entering the study, which ever is their choice, then we will go along with their wishes, even if it goes against your wishes.
If after reading this information sheet, and thinking it over for a few days and after discussing it with your child, you decide not to participate, then that is OK. It will not affect your treatment or next visit to the clinic in any way.
Your consultant and the research nurse will arrange dates for your child's annual assessments. They will also organise a convenient time to see you, to take your blood and urine samples and apply the blood pressure monitor. We would of course reimburse any additional travel expenditure or loss of earnings that you incur, subject to the provision of receipts.
Your involvement in this study is entirely voluntary and you are free to withdraw at any stage without affecting your child's care in the diabetes clinic in any way.
If you want to drop out of the study at a later date, all you need to do is tell your doctor or the nurse. If it were your wish, we would destroy all the samples already provided, including your DNA sample.
If you have any questions regarding this study, please contact us:
The UK GRID Clinical Resource Office Department of Paediatrics, Box 116 Addenbrooke's Hospital Hills Road, Cambridge, CB2 2QQ Tel: 01223 763131
Email for Cambridge investigators:
ukgrid@paed.cam.ac.uk
On behalf of the Study Group for the Genetics of Type 1 diabetes, we would like to thank you for taking the time to consider participating in this important research programme.
| UK Children's Diabetes Research file: | http://www.childhood-diabetes.org.uk/info/neph-info-parents.shtml |
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| Written by: | Neil Walker |
| Last modified: | 28/10/2011 |