NCT05505669

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Mar 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Mar 2022Jun 2026

Study Start

First participant enrolled

March 29, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2026

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

4.2 years

First QC Date

July 31, 2022

Last Update Submit

January 26, 2026

Conditions

Diabetes

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (6)

Adults with type 1 diabetes

Adults with type 1 diabetes

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.

Adult healthy volunteers

Adult healthy volunteers

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.

Children with type 1 diabetes

Children with type 1 diabetes

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.

Adults with type 2 diabetes

Adults with type 2 diabetes

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.

Adults with high blood sugar

Adults with high blood sugar

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.

Those at risk of developing type 1 diabetes

Those at risk of developing type 1 diabetes

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.

Interventions

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.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.

Adult healthy volunteersAdults with high blood sugarAdults with type 1 diabetesAdults with type 2 diabetesChildren with type 1 diabetesThose at risk of developing type 1 diabetes

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants from the clinic environment/ local providers/ diabetes events, relatives/ friends of participants, employees, and normal healthy participants from the community

You may qualify if:

  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Urinary, saliva, plasma and serum samples are collected for future analysis

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Rupangi Vasavada, PhD

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

1-866-444-7538Islets@coh.org

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2022

First Posted

August 18, 2022

Study Start

March 29, 2022

Primary Completion (Estimated)

June 9, 2026

Study Completion (Estimated)

June 9, 2026

Last Updated

January 28, 2026

Record last verified: 2026-01

Locations

US(1)