RECRUITING

Circulating Biomarkers in the Development of Type 1 Diabetes

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Circulating Biomarkers of Beta Cell Loss/Dysfunction in Diabetes

Quick Facts

Study Start:2022-03-29
Study Completion:2025-12-21
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05505669

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Documented informed consent/ assent from the subject
  2. * ONE of the following:
  3. * Type 1 diabetes patients (including pediatric patients) -OR-
  4. * Adult type 2 diabetes patients -OR-
  5. * 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-
  6. * Adult participants with clinical diagnosis of high blood sugar (i.e. HbA1c of 5.7% to 6.4%)-OR-
  7. * Adult control subjects with HbA1cc ≤ 5.6%
  8. * Weight ≥ 30 kg
  9. * Willingness to: Provide blood sample(s) and if applicable: permit medical record/ clinical laboratory result review
  1. * Control subjects must not have any chronic conditions or have undergone cellular, tissue or organ transplant
  2. * 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)
  3. * Active infection
  4. * Active malignancy (i.e., currently undergoing treatment)
  5. * 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)
  6. * Type 1 diabetes only: polyclonal regulatory T cell and/or dendritic cell therapy
  7. * Bleeding disorder
  8. * Women of childbearing potential: Pregnant/ nursing (Note: Eligibility may be deferred per blood donation timelines for pregnancy/nursing)
  9. * Diabetic patients only: Any clinical condition that might be adversely affected by the removal of up to 100 mL of blood
  10. * An employee who is under the direct/ indirect supervision of the PI/ a co-investigator/ the study manager
  11. * A direct study team member

Contacts and Locations

Study Contact

Study Coordinator
CONTACT
1-866-444-7538
Islets@coh.org

Principal Investigator

Rupangi Vasavada, PhD
PRINCIPAL_INVESTIGATOR
City of Hope Medical Center

Study Locations (Sites)

City of Hope Medical Center
Duarte, California, 91010
United States

Collaborators and Investigators

Sponsor: City of Hope Medical Center

  • Rupangi Vasavada, PhD, PRINCIPAL_INVESTIGATOR, City of Hope Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-29
Study Completion Date2025-12-21

Study Record Updates

Study Start Date2022-03-29
Study Completion Date2025-12-21

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetes