NCT05505669 · City of Hope Medical Center
Circulating Biomarkers in the Development of Type 1 Diabetes
What this study 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.
View original scientific description
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.
Interventions
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.
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 outcome measures
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Duarte, California
Collaborators
Icahn School of Medicine at Mount Sinai, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 24, 2026 · Source of record for eligibility and locations