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

This study is currently recruiting participants.
Verified January 2014 by City of Hope Medical Center
Sponsor:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01176253
First received: August 4, 2010
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Type 1 Diabetes Mellitus
Procedure: Blood draw

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Detection of Human Beta Cell Death in T1DM by Methylation Specific PCR

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • 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. [ Time Frame: 1 year post diagnosis ] [ Designated as safety issue: No ]
  • Use the assays to detect beta cell destruction throughout the early time-course of type 1 diabetes mellitus [ Time Frame: 1 year post diagnosis ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: July 2009
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
25 newly diagnosed Type 1 diabetics
25 newly diagnosed Type 1 diabetics within onset of symptoms
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
25 healthy volunteers
25 healthy volunteers (age & sex matched)
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Type I Diabetic, newly diagnosed, >18 years of age

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01176253

Contacts
Contact: Sachiko Paz (626) 256-4673 ext 65994 spaz@coh.org
Contact: Cindy Stahl, RN 626 256-4673 ext 63709 cstahl@coh.org

Locations
United States, California
City of Hope National Medical Center-Department of Diabetes, Endocrinology, & Metabolism Recruiting
Duarte, California, United States, 91010
Contact: Sachiko Paz    626-256-4673 ext 65994    spaz@coh.org   
Contact: Cindy Stahl, RN    626 256-4673 ext 63709    cstahl@coh.org   
Principal Investigator: Kevin Ferreri, Ph.D.         
Sub-Investigator: Fouad Kandeel, MD, Ph.D.         
Loma Linda Medical Center Recruiting
Loma Linda, California, United States, 92354
Contact: Eba Hathout, MD    951-764-9894    EHathout@LLU.edu   
Contact: Leah Shelby, MD       LSelby@llu.edu   
Principal Investigator: Eba Hathout, MD         
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Kevin Ferreri, Ph.D. City of Hope Medical Center
  More Information

Publications:

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01176253     History of Changes
Other Study ID Numbers: 08078
Study First Received: August 4, 2010
Last Updated: January 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:
Type I DM

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014