Circulating Biomarkers in the Development of Type 1 Diabetes

Diabetes Clinical Trial

Official title:

Circulating Biomarkers of Beta Cell Loss/Dysfunction in Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05505669
• Other study ID #: 20477
• Secondary ID: R01DK125856
• Status: Recruiting
• Start date: March 29, 2022
• Est. completion date: December 21, 2026

Study information

• Verified date: August 2023
• Source: City of Hope Medical Center
• Contact: Study Coordinator
• Phone: 1-866-444-7538
• Email: Islets[@]coh.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 165
• Est. completion date: December 21, 2026
• Est. primary completion date: December 21, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (3)

Lead Sponsor	Collaborator
City of Hope Medical Center	Icahn School of Medicine at Mount Sinai, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of circulating biomarkers that correlate with beta cell death in type 1 diabetes compared to healthy controls	The measure will be changes in beta cell death.	Baseline
Primary	Changes in frequency of circulating biomarkers that correlate with beta cell death from type 1 diabetes patients compared to other cohorts	The measure will be changes in beta cell death.	Baseline