Type 1 Diabetes MellitusNCT01176253
Detection of Human Beta Cell Death in Type 1 Diabetes Mellitus (T1DM) by Methylation Specific Polymerase Chain Reaction (PCR)
An observational study of Type 1 Diabetes Mellitus, run by City of Hope Medical Center at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Blood draw
- Type of treatment
- Surgery or procedure
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2009to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Type I Diabetic, newly diagnosed, >18 years of age
Who may be able to join
- 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,
Show all 9Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
City of Hope National Medical Center-Department of Diabetes, Endocrinology, & Metabolism
Duarte, California, 91010
Loma Linda Medical Center
Loma Linda, California, 92354
About this study
Official title: Detection of Human Beta Cell Death in T1DM by Methylation Specific PCR
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.
Read the 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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Blood draw
- Keywords
- Type I DM
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 25 newly diagnosed Type 1 diabetics | 25 newly diagnosed Type 1 diabetics within onset of symptoms Receives: Procedure: Blood draw | |
| 25 healthy volunteers | 25 healthy volunteers (age \& sex matched) Receives: Procedure: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year post diagnosis
Use the assays to detect beta cell destruction throughout the early time-course of type 1 diabetes mellitus
Measured: 1 year post diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2010 (estimated)
- Study startJul 2009
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Ferreri, Ph.D., Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176253
- Sponsor's protocol ID
- 08078
- Status last verified
- Apr 2015
- First submitted
- 4 Aug 2010
- Last updated
- 1 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 11708462Schutz 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.
PubMed 16002628Tong 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.
PubMed 16126188Galm O, Herman JG. Methylation-specific polymerase chain reaction. Methods Mol Med. 2005;113:279-91. doi: 10.1385/1-59259-916-8:279.
PubMed 15968111Koike 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.
PubMed 15334633Liu 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.
PubMed 14740499Gierl 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.
PubMed 16951258Wang 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.
PubMed 16855267
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Human Beta Cell Death in T1DM by Methylation Specific PCR
- ClinicalTrials.gov ID
- NCT01176253
- Acronym / sponsor ID
- 08078
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type I DM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 5 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 25 newly diagnosed Type 1 diabetics | – | Procedure: Blood draw25 newly diagnosed Type 1 diabetics within onset of symptoms |
| 25 healthy volunteers | – | Procedure: Blood draw25 healthy volunteers (age \& sex matched) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Type I Diabetic, newly diagnosed, >18 years of age
Key inclusion criteria (9 listed)
- Age > 18 years of age,
- Otherwise healthy individuals with no cancer and not pregnant.
- Newly diagnosed type I diabetes,
- Age > 18 years of age,
- Otherwise healthy individuals with no severe complications, no cancer, not pregnant,
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawBlood draw for Type I DM patients will be taken every 4 weeks for 1 year post diagnosis/healthy volunteers will have 1 blood draw | Procedure or surgery | 25 healthy volunteers, 25 newly diagnosed Type 1 diabetics |
Primary outcome
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
Use the assays to detect beta cell destruction throughout the early time-course of type 1 diabetes mellitus
Time frame: 1 year post diagnosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2015.
- Background: PubMed 11708462Lo 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.
- Background: PubMed 16002628Schutz 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.
- Background: PubMed 16126188Tong 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.
- Background: PubMed 15968111Galm O, Herman JG. Methylation-specific polymerase chain reaction. Methods Mol Med. 2005;113:279-91. doi: 10.1385/1-59259-916-8:279.
- Background: PubMed 15334633Koike 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.
- Background: PubMed 14740499Liu 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.
- Background: PubMed 16951258Gierl 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.
- Background: PubMed 16855267Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Ferreri, Ph.D. principal investigator
City of Hope Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus, run by City of Hope Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01176253, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2015.