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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Detection of Human Beta Cell Death in T1DM by Methylation Specific PCR

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01176253
• Other study ID #: 08078
• Status: Completed
• Phase: N/A
• First received: August 4, 2010
• Last updated: April 29, 2015
• Start date: July 2009
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
United States	City of Hope National Medical Center-Department of Diabetes, Endocrinology, & Metabolism	Duarte	California
United States	Loma Linda Medical Center	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
City of Hope Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (8)

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

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Use the assays to detect beta cell destruction throughout the early time-course of type 1 diabetes mellitus		1 year post diagnosis	No