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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 25 newly diagnosed Type 1 diabetics | 25 newly diagnosed Type 1 diabetics within onset of symptoms |
| |
| 25 healthy volunteers | 25 healthy volunteers (age & sex matched) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Healthy volunteers:
Type 1DM:
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Type I Diabetic, newly diagnosed, >18 years of age
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Ferreri, Ph.D. | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope National Medical Center-Department of Diabetes, Endocrinology, & Metabolism | Duarte | California | 91010 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11708462 | Background | 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. | |
| 16002628 | 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. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Loma Linda Medical Center |
| Loma Linda |
| California |
| 92354 |
| United States |
| 16126188 | 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. |
| 15968111 | 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. |
| 15334633 | 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. |
| 14740499 | 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. |
| 16951258 | 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. |
| 16855267 | 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. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |