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NCT Number: NCT01176253

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

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

City of Hope National Medical Center-Department of Diabetes, Endocrinology, & Metabolism, Duarte, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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

  2. Use the assays to detect beta cell destruction throughout the early time-course of type 1 diabetes mellitus

    Time frame: 1 year post diagnosis

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Aug 5, 2010
Registry last updated
May 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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