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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01176253

Enrollment

Registered

2010-08-05

Start date

2009-07-31

Completion date

2015-04-30

Last updated

2015-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

Keywords

Type I DM

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.

Interventions

PROCEDUREBlood 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

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026