[Name of Institution]
Information and Consent for Screening Step 2
Diabetes Prevention Program (DPP)
Investigators
- Name of Principal Investigator
-
Title, Affiliation, Phone Number
- Name of Co-Investigator(s)
-
Title, Affiliation, Phone Number
- Name of Program Coordinator
-
Title, Affiliation, Phone Number
- Name of Recruitment Coordinator
-
Title, Affiliation, Phone Number
- 24-Hour Emergency Telephone Number
-
[List phone number(s) here]
Investigator's Statement
Purpose
This research study is called the Diabetes Prevention Program (DPP). This study
will test several ways to prevent the common form of diabetes (type 2 diabetes,
also called non-insulin-dependent diabetes mellitus or NIDDM). The purpose of this
part of screening for DPP is to find out more about your risk for getting type 2
diabetes by doing an oral glucose tolerance test. If this test shows you have impaired
glucose tolerance (also called IGT) and other conditions are met, you will be offered
the chance to join DPP.
Benefits
By doing the oral glucose tolerance test, early detection of diabetes is possible.
From this test, we will be able to tell whether you have diabetes, IGT, or normal
glucose tolerance. You may choose not to find this out by not taking part in this
test. If the test suggests that you might have diabetes, you will be referred to
a doctor of your choice for treatment. If you do not have a doctor, we will help
you to find a doctor for treatment.
Procedures
You will be asked to not eat or drink anything, except water, for 12 hours before
your appointment.
1. Height, weight, and blood pressure will be checked (if not done previously).
This will take about 10 minutes.
2. A blood sample, about 1 teaspoon, will be taken from your arm and the glucose
level measured right away. You will also be asked to give a urine sample. This will
take about 15 minutes.
3. Depending upon the level of glucose in this test, an oral glucose tolerance test
will be done. Another blood sample, about 2 tablespoons, will be taken from your
arm (this might be postponed until a later visit). You will then be asked to drink
a glassful of flavored sugar water over 5 to 10 minutes. Another blood sample, about
1 tablespoon, will be taken from your arm at 30 and again at 120 minutes later.
This test will take up to 2 and 1/2 hours.
Risks and Discomforts
The risks of drawing blood include temporary discomfort from the needle stick, and
possible bruising or redness of the skin. About one out of ten people have mild
nausea or an upset stomach with the glucose (sugar) drink that is given during the
oral glucose tolerance test. You might feel uncomfortable about some of the questions
asked of you. You may choose not to answer any questions.
Other Information
[Institutional language as suggested by your IRB may be substituted for the following
sections.]
Information that we get from you will be kept confidential to the extent allowed
under law. You are free to take back your consent and stop taking part at any time.
You may ask any questions about the study at any time. All study procedures will
be free of charge.
If you are hurt as a direct result of the study, medical treatment will be done
at no cost within the limits of our compensation plan. Beyond this, treatment will
be at your expense or that of your insurance carrier.
If you have any more questions about your rights as a research subject, you may
call [name of IRB contact] at [IRB phone number].
________________________________________________________________
Investigator's Signature Date
Participant's Statement
The study described above has been explained to me. I understand that I am consenting
to participate in this part of the study. If I have any questions about the study,
I know that I can contact any of the persons listed on the first page.
________________________________________________________________
Participant's Signature Date
|
cc:
|
Investigator
|
|
|
Participant
|
|