Detection of Human Beta Cell Death in Type 1 Diabetes Mellitus (T1DM) by Methylation Specific Polymerase Chain Reaction (PCR)
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About
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.
Full description
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.
Enrollment
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Inclusion and exclusion criteria
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.
Trial design
6 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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