Diabetes has no symptoms in early stages,
often goes 10
years before it is diagnosed.
Many
people already have diabetes complications
at time of
diagnosis.
We need a screening test to help recognize
the earliest
stages – “pre-diabetes” (IGT).
Earlier
diagnosis will allow preventive therapy.
The
SIGT study will develop this new test.
IGT Itself Is a Problem
Pre-diabetes
(IGT) itself can cause heart attacks
and stroke.
Over
35 million Americans have pre-diabetes (IGT)
and
don’t
know it.
They
are not detected and not treated because
we do not
know
how to screen for
IGT
-- to find it easily,
conveniently,
and inexpensively.
SIGT
Study Objective
This
study will develop a screening test
to identify
people
with
pre-diabetes (IGT)
much
earlier in their lives.
Finding these people early should let them get medical
care to
help prevent diabetes,
heart attacks, and stroke.
Who
Will Be in the SIGT Study?
Study
participation is voluntary.
Volunteers
for the study will include employees at Grady, Emory,
and Morehouse, as well as some family members.
We hope that about 2,100 volunteers will take part in
the study.
Study
begins January 1, 2005, and will last for 3 years.
Who Is Eligible?
If
you have not been told that you have diabetes now…
If
you have not been ill within the last week
(needing to
miss work)…
We
are asking you to volunteer for the study.
What
is Involved?
The
study will involve only two visits,
with blood tests, a urine sample, and questionnaires.
Visits at General Clinical Research Center
(GCRC) at Emory University Hospital [GG], or
(GCRC) at Grady Memorial Hospital [8A].
The
first visit will take a bit more than an hour,
and the
second visit will
take a bit more than
two hours.
The
two visits will be within two weeks of each other.
IGT Study - Visit 1
Glucose
challenge test (GCT):
any time of the day (7 am to 5 pm)
OK to eat before the test
blood
samples (fingerstick, vein in arm)
10
ounce (one cup) sugar drink
repeat
blood samples one hour later
IGT
Study - Visit 2
Oral
glucose tolerance test (OGTT):
in the morning before 11 am
no
food or drink except water
for 8 hours before the test
blood
sample from vein in arm
10
ounce (one cup) sugar drink
repeat
blood samples 1 and 2 hours later
Heart
Risk Tests (HRT):
blood sample from vein in arm
(cholesterol, etc.)
urine
test for kidney function
body
measurements
(height, weight, blood pressure, etc.)
simple
questionnaires
(family history of diabetes, heart disease,
exercise, eating habits, etc.)
IGT
Study – The Need
Asking
you to participate in this study may seem to be asking
a lot.
BUT
diabetes is a very big problem.
We
will not be able to overcome it unless many of us
– people who do not think
that they have diabetes
now– PITCH IN
TO HELP.
What Will be Done With the Information
We
will find out how to screen for pre-diabetes (IGT).
We will also find out how well the test works in people
who
are old or young, heavy or thin, who do or don’t
exercise, or who have different
racial or ethnic backgrounds.
What
Do You Get from the Study?
Time for taking part in the study will not be taken out
of sick leave or vacation.
You
will be given your test results.
We
will explain what the results mean.
If tests show that you have pre-diabetes or risk of
heart
problems,
we will tell you
what you and
your doctors can do.
If you have these problems, you will get a “head
start” to improve your health.
Depending
on your test results, you may be offered an opportunity
to participate in
additional research studies.
These
additional research studies will evaluate your risk of
diabetes and heart problems
in more detail.
The
studies may include new treatments to reduce the risk
of diabetes and heart
problems – a further “head start” to
improve your health.
What Does Society Get?
The
information from this study should help improve
care
for
all people, since the goal
is to develop a new
screening
test which would be used
in routine medical
practice.
Risks
of the Study
Standard
blood draws and fingersticks
(total blood for all the tests will be three tablespoonfuls).
Drinking 10 ounces of sweetened liquid
(sugar content
of 2 soft drinks).
There
is no risk in obtaining urine samples, physical measurements,
or filling out
questionnaires.
Confidentiality
All
information will be kept private. The results will not
be part of your medical record.
Insurance
companies will not have access to these results.
The
results of this study will be published in medical journals
and presented at medical
meetings. All test results will be grouped so that individuals
cannot be recognized.
This
study has strong support from the leaders of Emory and
Emory HealthCare
(President Wagner and Dr. Michael Johns), Grady (Dr. Andrew
Agwunobi), and
Morehouse (Dr. James Gavin).
However,
neither Emory nor Grady nor Morehouse will know whether
individuals have been
in the study, or what their results are.
Is the SIGT Study for You?
Participation
in research is VOLUNTARY.
You have the right to refuse to participate.
If
you decide to be in the study and later change
your mind,
you have the right to drop
out at any time.
Whatever
you decide, you will not lose any benefits
to which you
are otherwise entitled.
SIGT Study Information
Information
Forms and Consent Forms are provided in the links listed
below:
Information
Form
Consent
Form
If
interested in volunteering for the SIGT Study:
call Emory Health Connection, 404-778-7777
- we will contact you, schedule study visits.
For
other questions about the study:
SIGT Study Office, 404-727-1373
Deborah Stout, RN
For
questions about the research plan:
Lawrence Phillips, MD, 404-712-4722
Summary – SIGT Study
Pre-diabetes
(IGT) is a major health problem,
but we don’t screen
for it to find it early.
SIGT
study will develop a new screening test.
Study
participants will:
- get useful personal health information
- help society by developing the new test
Earlier
diagnosis should permit management
to be more effective
to sustain health.
The
goal of this project is to revolutionize
diabetes care;
screening for IGT should be
like screening for breast
cancer
or prostate
cancer.
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