NCT01176253

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 6 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
PROCEDURE	Blood draw	Blood draw for Type I DM patients will be taken every 4 weeks for 1 year post diagnosis/healthy volunteers will have 1 blood draw

Timeline

• Start date: 2009-07-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2010-08-05
• Last updated: 2015-05-01

Locations

2 sites across 1 country: United States