Understanding biomarkers in the development of Type 1 diabetes

Circulating Biomarkers of Beta Cell Loss/Dysfunction in Diabetes

This study is trying to see how certain biological markers in blood, saliva, and urine can help us understand and possibly spot Type 1 diabetes earlier in people who have it or are at risk.

Quick facts

• Study type: Observational
• Enrollment: 165 (estimated)
• Sex: All
• Sponsor: City of Hope Medical Center (Academic / other)
• Locations: 1 site (Duarte, California)
• Trial ID: NCT05505669 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore the role of circulating biomarkers in the development of Type 1 diabetes. It involves collecting blood, saliva, and urine samples from participants to analyze biological molecules that may indicate the presence or progression of diabetes. The research focuses on understanding the biology of insulin-producing beta cells in the pancreas, which could lead to early diagnosis and new therapies for diabetes. Participants include those with Type 1 diabetes, Type 2 diabetes, and individuals with specific auto-antibodies or high blood sugar levels.

Who should consider this trial

Good fit: Ideal candidates include individuals with Type 1 diabetes, Type 2 diabetes, islet auto-antibody positive volunteers, or adults with high blood sugar levels.

Not a fit: Patients with chronic conditions, active infections, or malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier diagnosis and improved treatment options for diabetes.

How similar studies have performed: Other studies have shown promise in identifying biomarkers for diabetes, suggesting that this approach could yield valuable insights.

Eligibility criteria

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 this trial is running

Duarte, California

• City of Hope Medical Center — Duarte, California, United States (Recruiting)

Study contacts

• Principal investigator: Rupangi Vasavada, PhD — City of Hope Medical Center
• Study coordinator: Study Coordinator

Conditions Diabetes