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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Procedure: Blood draw


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 25 newly diagnosed Type 1 diabetics<br>25 newly diagnosed Type 1 diabetics within onset of symptoms | Procedure: Blood draw<br>* 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<br>|
| 25 healthy volunteers<br>25 healthy volunteers (age & sex matched) | Procedure: Blood draw<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Develop sensitive, specific, and quantitative methylation- specific PCR assays for the detection of human beta cell-specific DNA methylation patterns cells and the onset of metabolic dysregulation. |  | 1 year post diagnosis | 
| Use the assays to detect beta cell destruction throughout the early time-course of type 1 diabetes mellitus |  | 1 year post diagnosis | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type I DM