Circulating Biomarkers in the Development of Type 1 Diabetes
ConditionDiabetes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorCity of Hope Medical Center
About this trial
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
This trial accepts healthy volunteersQualifiers
Documented informed consent/ assent from the subject
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-
Disqualifiers
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)
Trial population
Participants from the clinic environment/ local providers/ diabetes events, relatives/ friends of participants, employees, and normal healthy participants from the community
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
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 interventionOne-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.
Treatment groups
165 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Adults with type 1 diabetes1 intervention
Group B: Adult healthy volunteers1 intervention
Group C: Children with type 1 diabetes1 intervention
Group D: Adults with type 2 diabetes1 intervention
Group E: Adults with high blood sugar1 intervention
Group F: Those at risk of developing type 1 diabetes1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline2
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.
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
City of Hope Medical Center
Lead sponsor
Icahn School of Medicine at Mount Sinai
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov