Circulating Biomarkers in the Development of Type 1 Diabetes
Recruiting
Observational Study
Diabetes
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Sex
Any
Study type
Observational
Participants needed
165 (estimated)
Sponsor
City of Hope Medical Center · Other
Who this trial is looking for
This trial is looking for people with type 1 or type 2 diabetes, as well as healthy volunteers. Participants will provide blood samples and undergo a review of their medical records to help understand diabetes better.
Are You a Good Fit for This Trial?
Rules you outActive infectionCancerSickle cell diseaseBleeding disorder
You may be able to join if
I have been diagnosed with type 1 diabetes
I have been diagnosed with type 2 diabetes
I am a volunteer who has islet auto-antibodies
I have high blood sugar levels
I am a healthy adult control subject
I weigh at least 30 kg
I am willing to provide blood samples
I can allow review of my medical records
You may not be able to join if
I have a chronic condition or had an organ transplant
I have sickle cell disease or anemia that isn't treated
I have an active infection
I have an active cancer and am currently in treatment
I have taken immunomodulatory therapy in the past year
I have had specific therapies for type 1 diabetes recently
I have a bleeding disorder
I am pregnant or nursing
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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 Locations
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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 ant…
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
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