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. (see Contacts and Locations)
Verified July 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: July 31, 2014
Last verified: July 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 2016
Estimated Primary Completion Date: June 2016 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Suspended
Duarte, California, United States, 91010
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: July 31, 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 August 19, 2014