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

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Procedure: Blood draw

• Registration Number: NCT01176253
• Lead Sponsor: City of Hope Medical Center

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.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2010-08-04
• Study First Submitted QC: 2010-08-04
• Study First Posted: 2010-08-05
• Status Verified: 2015-04
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Last Update Submitted: 2015-04-29
• Last Update Posted: 2015-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
25 healthy volunteers	Blood draw	25 healthy volunteers (age \& sex matched)
25 newly diagnosed Type 1 diabetics	Blood draw	25 newly diagnosed Type 1 diabetics within onset of symptoms

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Loma Linda Medical Center; 🇺🇸 Loma Linda, California, United States

City of Hope National Medical Center-Department of Diabetes, Endocrinology, & Metabolism; 🇺🇸 Duarte, California, United States