CHILDREN'S HOSPITAL AND
ASSENT FORM
PRECURSORS TO
DIABETES IN JAPANESE AMERICAN YOUTH
Principal Investigator:
Co-Investigators:
24 hour emergency phone
number:
University of
Doctor's
Statement:
We
are doing a research study to understand how children's bodies use food and how
their bodies make fat. There is nothing
wrong with your body, and you are not sick.
Children who are in this study will have a chance to ask lots of
questions about how the right kinds of food and exercise can keep them
healthy. By studying healthy children
like you, we can learn more about helping children who are sick with a problem
called diabetes. Diabetes happens when
the body can't use food in all the ways it is supposed to.
If
you want to be in this study, you will come to the clinic two times. The first time, you will go to another
building nearby and have 2 kinds of tests that look at the fat in your
body. For one of these, you will have to
lie still on a table for a few minutes.
For the others, you will have to lie still for about 20 minutes. Then, you will come to the clinic. We will measure how tall you are, how much
you weigh, measure the size of your tummy and hips with a tape measure, and do
a physical exam. We will ask you to try
to remember all the different foods you ate
yesterday. We will also ask you what you
did yesterday. For example we might ask
you "Did you play on the playground during recess yesterday?". Your parents
will answer questions about the whole family, and about your health. We will also take some blood samples. This will mean a poke in the arm. We will take the needle out right away, but
we will leave a small, soft plastic tube in your arm so that we can draw more
blood without poking you again. We will
put a little bit of sugar water into the tube in your arm, and then take small
amounts of blood out every few minutes.
You will need to sit or lay down while the tube is in your arm, but you
can read, watch TV, or play games while you are waiting for us to finish. We will take the tube out of your arm in one
hour. You will be asked to go without
food or drinks (except for water) the night before you come in for these
samples. Two years from now, we will ask
you to come back and do the whole thing again.
The
poke for the blood sample might hurt for a little while. Sometimes there's a bruise on the skin later
on. It also might hurt a little bit when
we put the sugar water in your arm. Very
rarely, the pain may last for several days.
Some children feel embarrassed when they undress for the physical exam. If you want, your mom or dad can be with you
during the exam. If you'd rather just
have the doctor and the nurse there during your exam, that's OK too.
You
will receive a gift certificate after each visit, as our way of thanking you
for taking part in the study.
You
don't have to be in this study if you don't want to. You can change your mind
at any time and tell us you want to stop.
We'll answer all of your questions any time.
Doctor's
Signature__________________________
Date_______________
Child's
Statement:
The
doctor has told me about this study. I
want to be in it.
Child's
Signature_________________________Date_____________________________
Parent's
Signature_________________________Date_____________________________
Copies to: Subject/Parent
Investigator's file