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NCT Number: NCT05505669

Circulating Biomarkers in the Development of Type 1 Diabetes

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.

Recruiting

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

Location status: Recruiting

Location contact

Study Coordinator

CONTACT

[email protected]

866-444-7538

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Documented informed consent/ assent from the subject
  • ONE of the following:
  • Type 1 diabetes patients (including pediatric patients) -OR-
  • Adult type 2 diabetes patients -OR-
  • Volunteers who are islet auto-antibody positive (i.e. insulin, GAA, IA-2, IAA and ZnT8 antibodies) with HbA1c ≤ 5.6% (including pediatric patients)-OR-
  • Adult participants with clinical diagnosis of high blood sugar (i.e. HbA1c of 5.7% to 6.4%)-OR-
  • Adult control subjects with HbA1cc ≤ 5.6%
  • Weight ≥ 30 kg
  • Willingness to: Provide blood sample(s) and if applicable: permit medical record/ clinical laboratory result review

Exclusion criteria

  • Control subjects must not have any chronic conditions or have undergone cellular, tissue or organ transplant
  • Sickle cell disease or anemia (exception: anemia that is corrected with treatment and source documents confirm corrected blood parameters current within 6 months of blood draw)
  • Active infection
  • Active malignancy (i.e., currently undergoing treatment)
  • Immunomodulatory therapy within 1 year of planned blood draw (may include immune checkpoint inhibitors, thalidomide, lenalidomide, pomalidomide, imiquimod, Bacillus Calmette-Guérin, and cytokines/ growth factors (e.g. interferons, interleukins)
  • Type 1 diabetes only: polyclonal regulatory T cell and/or dendritic cell therapy
  • Bleeding disorder
  • Women of childbearing potential: Pregnant/ nursing (Note: Eligibility may be deferred per blood donation timelines for pregnancy/nursing)
  • Diabetic patients only: Any clinical condition that might be adversely affected by the removal of up to 100 mL of blood
  • An employee who is under the direct/ indirect supervision of the PI/ a co-investigator/ the study manager
  • A direct study team member

Treatment and study plan

One-time blood (up to 100 ml) will be drawn and the amount of blood drawn is based on weight. Saliva and urine will be collected during the blood draw visit.

Other

One-time blood (up to 100 ml) will be drawn and the amount of blood drawn is based on weight. Saliva and urine will be collected during the blood draw visit.

Primary outcomes

  1. Identification of circulating biomarkers that correlate with beta cell death in type 1 diabetes compared to healthy controls

    Time frame: Baseline

    The measure will be changes in beta cell death.

  2. Changes in frequency of circulating biomarkers that correlate with beta cell death from type 1 diabetes patients compared to other cohorts

    Time frame: Baseline

    The measure will be changes in beta cell death.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Coordinator

CONTACT

[email protected]

1-866-444-7538

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • Icahn School of Medicine at Mount Sinai
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Circulating Biomarkers of Beta Cell Loss/Dysfunction in Diabetes

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
Aug 18, 2022
Registry last updated
Jun 24, 2026

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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