Detection of Human Beta Cell Death in Type 1 Diabetes Mellitus (T1DM) by Methylation Specific Polymerase Chain Reaction (PCR)



Status:Recruiting
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/13/2015
Start Date:July 2009
End Date:June 2016
Contact:Sachiko Paz
Email:spaz@coh.org
Phone:(626) 256-4673

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Detection of Human Beta Cell Death in T1DM by Methylation Specific PCR

To investigate the use of methylation-specific PCR (MSP) assays to detect human beta
cell-specific gene methylation patterns in serial blood samples drawn from newly diagnosed
Type 1 diabetics.

The study will follow 25 newly diagnosed type 1 diabetic patients from the onset of symptoms
to one year post-diagnosis. A total of 11 fasting blood draws will be taken, the first near
the time of diabetes diagnosis, then 2 weeks later, monthly for the next 6 months, and every
other month until 12 months. Each blood sample will be evaluated by the MSP assay, as well
as for measurement of fasting plasma glucose, HbA1c, c-peptide, and autoantibodies. The
study will also need 25 healthy volunteers to help us match some DNA markers needed for this
data. Healthy volunteers will be se=matched healthy individuals who have one blood sample
drawn.

Inclusion Criteria:

Healthy volunteers:

- Age > 18 years of age,

- Otherwise healthy individuals with no cancer and not pregnant.

Type 1DM:

- Newly diagnosed type I diabetes,

- Age > 18 years of age,

- Otherwise healthy individuals with no severe complications, no cancer, not pregnant,

- Willing and able to comply with the scheduled visits to the clinic for blood
sampling,

- Remain under the continuing care of an Endocrinologist.
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Loma Linda, California 92354
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