Clinical trial NCT01176253: Detection of Human Beta Cell Death in Type 1 Diabetes Mellitus (T1DM) by Methylation Specific Polymerase Chain Reaction (PCR)
Official title: Detection of Human Beta Cell Death in T1DM by Methylation Specific PCR
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus
Keywords: Type I DM
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
First posted: 2010-08-05
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type I Diabetic, newly diagnosed, \>18 years of age

Brief 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.

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 1 year post diagnosis
measure: Use the assays to detect beta cell destruction throughout the early time-course of type 1 diabetes mellitus
timeFrame: 1 year post diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center-Department of Diabetes, Endocrinology, & Metabolism
state: California
city: Loma Linda
country: United States
facility: Loma Linda Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Kevin Ferreri, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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