Circulating Biomarkers in the Development of Type 1 Diabetes

Recruiting

• Conditions: 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.

• Registration Number: NCT05505669
• Lead Sponsor: City of Hope Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-29
• Study First Submitted: 2022-07-31
• Study First Submitted QC: 2022-08-16
• Study First Posted: 2022-08-18
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-28
• Primary Completion: 2025-12-21
• Study Completion: 2025-12-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 165

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adults with high blood sugar	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.	Adults with high blood sugar
Children with type 1 diabetes	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.	Children with type 1 diabetes
Adults with type 2 diabetes	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.	Adults with type 2 diabetes
Those at risk of developing type 1 diabetes	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.	Those at risk of developing type 1 diabetes
Adults with type 1 diabetes	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.	Adults with type 1 diabetes
Adult healthy volunteers	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.	Adult healthy volunteers

Primary Outcome Measures

Name	Time	Method
Identification of circulating biomarkers that correlate with beta cell death in type 1 diabetes compared to healthy controls	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	Baseline	The measure will be changes in beta cell death.

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States