Actively Recruiting

All Genders
Healthy Volunteers
NCT05505669

Circulating Biomarkers in the Development of Type 1 Diabetes

Led by City of Hope Medical Center · Updated on 2026-01-28

165

Participants Needed

1

Research Sites

219 weeks

Total Duration

On this page

Sponsors

C

City of Hope Medical Center

Lead Sponsor

I

Icahn School of Medicine at Mount Sinai

Collaborating Sponsor

AI-Summary

What this Trial Is About

More than 100 million U.S. adults are now living with diabetes or prediabetes. Investigators still do not fully understand how diabetes develops and how the disease worsens. Insulin is a hormone that helps the body use sugar as a fuel and control blood-sugar levels. People with diabetes have problems making insulin. This is because their insulin-producing beta cells -in the pancreas-are damaged or destroyed. A biomarker is a biological molecule (such as DNA, RNA (the genetic material of cells) or protein) that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker can be measured and found in blood and/or other body fluids (such as saliva and urine). Understanding the biology of beta cells could help find diabetes-related biomarkers. The discoveries from this research could help with early diagnosis of diabetes and lead to the creation of therapies for treating diabetes.

CONDITIONS

Official Title

Circulating Biomarkers in the Development of Type 1 Diabetes

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide documented informed consent or assent
  • Have one of the following: type 1 diabetes (including children), adult type 2 diabetes, islet auto-antibody positive with HbA1c ≤ 5.6% (including children), adult with high blood sugar (HbA1c 5.7% to 6.4%), or adult control with HbA1c ≤ 5.6%
  • Weigh at least 30 kg
  • Willing to provide blood samples and allow medical record or lab result review if applicable
Not Eligible

You will not qualify if you...

  • Control subjects cannot have chronic conditions or history of cellular, tissue, or organ transplant
  • Have sickle cell disease or untreated anemia (anemia treated and documented within 6 months is allowed)
  • Have an active infection
  • Have active cancer and are undergoing treatment
  • Have had immunomodulatory therapy within 1 year before blood draw
  • Type 1 diabetes patients receiving polyclonal regulatory T cell or dendritic cell therapy
  • Have a bleeding disorder
  • Women of childbearing potential who are pregnant or nursing (eligibility may be delayed per blood donation guidelines)
  • Diabetic patients with conditions that could be harmed by blood removal of up to 100 mL
  • Are employees supervised directly or indirectly by the study investigators
  • Are a direct member of the study team

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

City of Hope Medical Center

Duarte, California, United States, 91010

Actively Recruiting

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Research Team

S

Study Coordinator

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

6

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