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

NCT01176253 | Completed DMC

• 1 other identifier: 08078
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

Type I DM

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

25 newly diagnosed Type 1 diabetics

25 newly diagnosed Type 1 diabetics within onset of symptoms

Procedure: Blood draw

25 healthy volunteers

25 healthy volunteers (age \& sex matched)

Procedure: Blood draw

Interventions

Blood draw PROCEDURE

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 newly diagnosed Type 1 diabetics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

Sponsors & Collaborators

• City of Hope Medical Center: lead

Study Sites (2)

City of Hope National Medical Center-Department of Diabetes, Endocrinology, & Metabolism

Duarte, California, 91010, United States

Location

Loma Linda Medical Center

Loma Linda, California, 92354, United States

Location

Related Publications (8)

• Lo YM. Circulating nucleic acids in plasma and serum: an overview. Ann N Y Acad Sci. 2001 Sep;945:1-7. doi: 10.1111/j.1749-6632.2001.tb03858.x.

  PMID: 11708462 BACKGROUND

• Schutz 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. doi: 10.1128/CDLI.12.7.814-820.2005.

  PMID: 16002628 BACKGROUND

• Tong YK, Lo YM. Diagnostic developments involving cell-free (circulating) nucleic acids. Clin Chim Acta. 2006 Jan;363(1-2):187-96. doi: 10.1016/j.cccn.2005.05.048. Epub 2005 Aug 26.

  PMID: 16126188 BACKGROUND

• Galm O, Herman JG. Methylation-specific polymerase chain reaction. Methods Mol Med. 2005;113:279-91. doi: 10.1385/1-59259-916-8:279.

  PMID: 15968111 BACKGROUND

• 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. doi: 10.1002/jso.20106.

  PMID: 15334633 BACKGROUND

• 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. doi: 10.2144/04361DD03.

  PMID: 14740499 BACKGROUND

• 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. doi: 10.1101/gad.381806.

  PMID: 16951258 BACKGROUND

• 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, Martin MG. Mutant neurogenin-3 in congenital malabsorptive diarrhea. N Engl J Med. 2006 Jul 20;355(3):270-80. doi: 10.1056/NEJMoa054288.

  PMID: 16855267 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Kevin Ferreri, Ph.D.

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2010
• First Posted: August 5, 2010
• Study Start: July 1, 2009
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 1, 2015

Record last verified: 2015-04

Locations

US (2)