NCT05505669 Circulating Biomarkers in the Development of Type 1 Diabetes
| NCT ID | NCT05505669 |
| Status | Recruiting |
| Phase | — |
| Sponsor | City of Hope Medical Center |
| Condition | Diabetes |
| Study Type | OBSERVATIONAL |
| Enrollment | 165 participants |
| Start Date | 2022-03-29 |
| Primary Completion | 2029-06-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 165 participants in total. It began in 2022-03-29 with a primary completion date of 2029-06-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Rupangi Vasavada, PhD
PRINCIPAL INVESTIGATOR
City of Hope Medical Center
Frequently Asked Questions
Who can join the NCT05505669 clinical trial?
This trial is open to participants of all sexes, studying Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05505669 currently recruiting?
Yes, NCT05505669 is actively recruiting participants. Contact the research team at Islets@coh.org for enrollment information.
Where is the NCT05505669 trial being conducted?
This trial is being conducted at Duarte, United States.
Who is sponsoring the NCT05505669 clinical trial?
NCT05505669 is sponsored by City of Hope Medical Center. The principal investigator is Rupangi Vasavada, PhD at City of Hope Medical Center. The trial plans to enroll 165 participants.
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