Recruiting

BiomarkersCirculating Biomarkers in the Development of Type 1 Diabetes

Sponsor:

City of Hope Medical Center

Code:

NCT05505669

Conditions

Diabetes

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

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.

Study Details

Brief summary:

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

Diabetes

Study ID

NCT05505669

Start date

Mar 29, 2022

Status verified date

Jun, 2026

Completion date

Jun 21, 2029

Anticipated

Primary completion date

Jun 21, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

165 participants

Anticipated

Interventions and Outcome Measures

Arms

Adults with type 1 diabetes

Adult healthy volunteers

Children with type 1 diabetes

Adults with type 2 diabetes

Adults with high blood sugar

Those at risk of developing type 1 diabetes

Interventions

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 measure

Identification of circulating biomarkers that correlate with beta cell death in type 1 diabetes compared to healthy controls [ Time Frame: Baseline ]
Changes in frequency of circulating biomarkers that correlate with beta cell death from type 1 diabetes patients compared to other cohorts [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Study Coordinator

1-866-444-7538 Islets@coh.org

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Study Coordinator

866-444-7538 Islets@coh.org

More Information

Sponsor

City of Hope Medical Center

Last update posted

Jun 24, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-06-24.