and
CHILDREN'S HOSPITAL AND
CONSENT FORM
PRECURSORS
TO DIABETES IN JAPANESE AMERICAN YOUTH
Principal
Investigator:
Edward Boyko, MD, MPH, Professor, Department of
Medicine,
Co-Investigators:
Graduate
Research Assistants:
24 hour emergency phone
numbers:
Dr. at University of
Dr.
Boyko at . Dr.
at Children's Hospital and
Investigator's Statement:
In
the past, type 2 diabetes has usually been seen in middle-aged and older
adults. In recent years, we are seeing more children with type 2 diabetes. We
think this is happening because children are overweight and less physically
active. Most children who develop type 2 diabetes get it around the time of
puberty. Some ethnic minority children, such as Native Americans, African
Americans, and Hispanics, seem to be at especially high risk. Based on information from studies of school
children in
In
this study we will ask you and your child to keep track of the types of foods
your child eats, and a dietitian will review this record with both you and your
child. Questions about the child's
physical activity, medical history and family history will also be asked. These
interviews will be conducted by members of our research staff. The dietitian will be available to answer any
questions you may have about your child’s diet and exercise habits. We will
also measure your child's blood pressure, cholesterol, and blood sugar level. We do not expect this study to directly
benefit your child. While we expect the test results will be normal, there is a
small chance that your child could benefit if these tests detect a problem
early on that can be treated by your child's regular doctor. We also hope the
information learned from this research may help doctors to give better care to
children in the future who have type 2 diabetes.
This
study involves two visits, one now and another one in two years. Each visit includes: a) the interviews with
you and your child described above, b) two different imaging tests to measure
body fat, c) a physical examination, and d) blood tests, which will be done
before and after an injection of a sugar water. The entire visit will take
about 4 hours. We will send you a letter
to arrange a second visit in two years.
The second visit will be the same as the first visit. We may send you another letter to see if your
child would be willing to return for additional visits in the next few years if
the study is approved to continue.
One
of the imaging tests is an x-ray called a DEXA scan. This test allows us to measure the amount of
fat, muscle, and bone in the body using a very small amount of x-rays. It will take about 20 minutes to set up the
machine and position the child, but the test itself takes about 6 – 7
minutes. The DEXA scan will be done at
The following are carried out at the Children’s Hospital and
We
will also take fasting blood samples.
Your child will need to go without food or drink, except for water, for
about 10 hours the night before the blood tests. We will place an intravenous (IV) catheter in
your child's arm so that we can draw several blood samples through the IV. This
way your child will only be poked one time for the blood samples that are
taken. When the IV is put in, we will draw blood to test for a variety of
factors related to type 2 diabetes, including blood sugar (glucose),
cholesterol, and several type of hormones.
We will then inject a small amount of sugar water through the IV, and
then draw several blood samples every few minutes for the next 40 minutes. The total amount of blood taken will be about
4 tablespoons (2 ounces) per visit. The
IV will be removed after about one hour.
We
will also collect DNA from the cells in the blood. DNA is how genes are coded in the body. Genes determine how the body is put together
so that the different parts of the body can work properly. We will use this DNA in future studies to
test for various genes to see how the body uses glucose, how it stores fat, and
other functions related to diabetes and heart disease. This information may help us to understand
how diabetes develops. However, there
are currently no DNA tests to diagnose heart disease or diabetes, and no
conclusions can be drawn about the health of a particular person based on these
DNA test results. This information will
be used for research purposes only. We
will not send you or your child the results of these DNA tests. If you do not want us to do tests on your
child's DNA, just mark the box at the bottom of this form that says No, and we
will not save a DNA sample. Your child
can still take part in the study even if you decide not to have your child’s
DNA stored permanently.
The
amount of radiation from the DEXA scan is about 3% of the total radiation that
the average person living in the
We
will send you a copy of your child's blood sugar and cholesterol results about 4
weeks after your visit. If the results
are abnormal, we will recommend that your child be evaluated by his or her
regular doctor. If you give us written
permission at the time of the visit, we will also send your child's doctor a
copy of these test results, as well as your child's height, weight and blood
pressure.
Participation
will be kept confidential, within the limits of the law. No names or other identifying information
will be used in any publications or presentations which may result from this
study. Only the study investigators and
staff will have access to identifying information such as name or medical
record number. We plan to keep this
information for 15 years after the last visit.
DNA samples will be kept in our laboratory and only the investigators
listed on this form, or those who have been given approval by these
investigators, will have access to the DNA.
DNA samples are identified by code, and the key linking the sample code
to an individual participant is kept in a secure location accessible only to
the investigators.
Your
child's participation is voluntary. You
or your child may choose not to participate and may withdraw from the study at
any time, without penalty or loss of benefits to which you or your child are
otherwise entitled.
As
a thank you for your child’s time, we will offer them their choice of a $25
gift certificate when they complete each visit. Examples of the gift
certificates include video rental, movie theaters, toy stores, activities
(roller skating, miniature golf), and sporting event tickets. Also, a parking voucher will be provided if
you need it.
In
the event of a physical injury as a direct result of participating in this
study, medical care will be available to your child at Children's Hospital and
For questions about your/your child’s rights as a
research participant, contact the hospital’s Institutional Review Board (IRB)
at (206) 526-2023. The IRB is a
committee who reviews the research to be sure that your/your child’s rights as
a research subject are protected.
_________________________________________
Signature
of Investigator Date
Parents' Statement:
The
study described above has been explained to me, and I voluntarily consent to have
my child participate in this research. I
have had the opportunity to ask questions and understand that future questions
I have about the research will be answered by the investigators listed above.
___________________________________________
Signature
of Parent/Legal Guardian Date
___________________________________________
Signature
of Parent/Legal Guardian Date
---------------------------------------------------------------------------------------------------------------------------------------
˙
No, I do not want my child’s
DNA to be stored for future research purposes.
˙ Yes, I agree to have my child’s DNA
stored for future research purposes.
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Copies
to: Parents
Investigator's
file