DiabetesNCT05505669
Circulating Biomarkers in the Development of Type 1 Diabetes
An observational study of Diabetes, run by City of Hope Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- 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.
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2022to 21 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants from the clinic environment/ local providers/ diabetes events, relatives/ friends of participants, employees, and normal healthy participants from the community
Who may be able to join
- 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-
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Study Coordinator, 866-444-7538, Islets@coh.org
About this study
Official title: Circulating Biomarkers of Beta Cell Loss/Dysfunction in Diabetes
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.
- Conditions
- Diabetes
- Being tested
- 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.
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Adults with type 1 diabetes | Adults with type 1 diabetes Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start29 Mar 2022
- Primary completion21 Jun 2029 (estimated)
- Study completion21 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Rupangi Vasavada, PhD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505669
- Sponsor's protocol ID
- 20477
- Other IDs
- R01DK125856
- Status last verified
- Jun 2026
- First submitted
- 31 Jul 2022
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Biomarkers of Beta Cell Loss/Dysfunction in Diabetes
- ClinicalTrials.gov ID
- NCT05505669
- Acronym / sponsor ID
- 20477
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- 21 Jun 2029 (estimated)
- Study completion
- 21 Jun 2029 (estimated)
- First posted
- 18 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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.Adults with type 1 diabetes |
| 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.Adult healthy volunteers |
| 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.Children with type 1 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 type 2 diabetes |
| 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.Adults with high blood sugar |
| 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.Those at risk of developing type 1 diabetes |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants from the clinic environment/ local providers/ diabetes events, relatives/ friends of participants, employees, and normal healthy participants from the community
Key inclusion criteria (9 listed)
- Documented informed consent/ assent from the subject
- ONE of the following:
- Weight ≥ 30 kg
- Willingness to: Provide blood sample(s) and if applicable: permit medical record/ clinical laboratory result review
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Adult healthy volunteers, Adults with high blood sugar, Adults with type 1 diabetes, Adults with type 2 diabetes, Children with type 1 diabetes, Those at risk of developing type 1 diabetes |
Primary outcome
Identification of circulating biomarkers that correlate with beta cell death in type 1 diabetes compared to healthy controls
Time frame: 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
Time frame: Baseline
The measure will be changes in beta cell death.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rupangi Vasavada, PhD principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (1-866-444-7538, Islets@coh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of circulating biomarkers that correlate with beta cell death in type 1 diabetes compared to healthy controls (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.