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 |
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.
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.
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.
We found this trial at
2
sites
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Duarte, California 91010
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