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

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:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Diabetes Diabetes Type 1

U.S. FDA Resources

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 2014
Estimated Primary Completion Date:	June 2014 (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: Blanca Herrera, BS	(626) 256-4673 ext 60719	bherrera@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: Blanca Herrera, BS 626-256-4673 ext 60719 bherrera@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.

Sponsors and Collaborators

City of Hope Medical Center

Investigators

Principal Investigator:

Kevin Ferreri, Ph.D.

City of Hope Medical Center

More Information

Publications:

Lo YM. Circulating nucleic acids in plasma and serum: an overview. Ann N Y Acad Sci. 2001 Sep;945:1-7. Review.

Schütz E, Urnovitz HB, Iakoubov L, Schulz-Schaeffer W, Wemheuer W, Brenig B. Bov-tA short interspersed nucleotide element sequences in circulating nucleic acids from sera of cattle with bovine spongiform encephalopathy (BSE) and sera of cattle exposed to BSE. Clin Diagn Lab Immunol. 2005 Jul;12(7):814-20.

Tong YK, Lo YM. Diagnostic developments involving cell-free (circulating) nucleic acids. Clin Chim Acta. 2006 Jan;363(1-2):187-96. Epub 2005 Aug 26. Review.

Galm O, Herman JG. Methylation-specific polymerase chain reaction. Methods Mol Med. 2005;113:279-91.

Koike H, Ichikawa D, Ikoma H, Otsuji E, Kitamura K, Yamagishi H. Comparison of methylation-specific polymerase chain reaction (MSP) with reverse transcriptase-polymerase chain reaction (RT-PCR) in peripheral blood of gastric cancer patients. J Surg Oncol. 2004 Sep 15;87(4):182-6.

Liu Q, Sommer SS. Detection of extremely rare alleles by bidirectional pyrophosphorolysis-activated polymerization allele-specific amplification (Bi-PAP-A): measurement of mutation load in mammalian tissues. Biotechniques. 2004 Jan;36(1):156-66.

Gierl MS, Karoulias N, Wende H, Strehle M, Birchmeier C. The zinc-finger factor Insm1 (IA-1) is essential for the development of pancreatic beta cells and intestinal endocrine cells. Genes Dev. 2006 Sep 1;20(17):2465-78.

Wang J, Cortina G, Wu SV, Tran R, Cho JH, Tsai MJ, Bailey TJ, Jamrich M, Ament ME, Treem WR, Hill ID, Vargas JH, Gershman G, Farmer DG, Reyen L, Martín MG. Mutant neurogenin-3 in congenital malabsorptive diarrhea. N Engl J Med. 2006 Jul 20;355(3):270-80.

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:	November 8, 2012
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 May 21, 2013