Circulating Biomarkers in the Development of Type 1 Diabetes
NCT ID: NCT05505669
Last Updated: 2025-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
165 participants
OBSERVATIONAL
2022-03-29
2025-12-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Adults with 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.
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
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.
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
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.
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
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.
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
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.
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
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
Yes
Sponsors
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Icahn School of Medicine at Mount Sinai
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Rupangi Vasavada, PhD
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20477
Identifier Type: -
Identifier Source: org_study_id
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