Clinical trial NCT05505669: Circulating Biomarkers in the Development of Type 1 Diabetes
Official title: Circulating Biomarkers of Beta Cell Loss/Dysfunction in Diabetes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-08-18
Enrollment: 165
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_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

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

Primary outcomes:
measure: Identification of circulating biomarkers that correlate with beta cell death in type 1 diabetes compared to healthy controls
timeFrame: Baseline
measure: Changes in frequency of circulating biomarkers that correlate with beta cell death from type 1 diabetes patients compared to other cohorts
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Rupangi Vasavada, PhD
role: PRINCIPAL_INVESTIGATOR
References: