Development of Novel Biomarkers for the Early Diagnosis of Type 1 Diabetes (HONEY)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.
Read our disclaimer for details.
The purpose of this study is to measure the levels of certain substances (biomarkers) in the body that may indicate the triggers of Type 1 Diabetes, to find a better way to diagnose the disease, as well as to follow its progression.
Characterization of circulating β cell-specific exosomes in children with T1D and healthy normal controls using baseline samples [ Time Frame: 2-3 hours ]
Measure will be the number (concentration) of circulating beta-cell specific exosomes. If the characterization of circulating beta-cell specific exosomes is not feasible in children with T1D due to the potentially limited low input amount of this type of exosomes in the circulation of these participants, an alternative analysis will be implemented.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
12 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Males and females 12-18 years of age with a diagnosis of type 1 diabetes within the past 3 months or those who do not have diabetes.
Type 1 Diabetes (T1D)
Age 12-18 years inclusive
Diagnosis of T1D according to American Diabetes Association (ADA) criteria with an acute onset and presence of islet associated autoantibody by history.
T1D duration of ≤ 3 months from the diagnosis
Healthy Normal Volunteers (HNV)
Age 12-18 years inclusive
No personal history of diabetes according to ADA criteria
No history of T1D or insulin treated diabetes in first degree relatives (FDR)
Acute or chronic medical conditions or medication that would contraindicate the participation in the research testing or could potentially affect metabolic and immune function including, but not limited to:
History of type 2 diabetes
Suspicion of non-type 1 diabetes (e.g. maturity onset diabetes of the young or secondary diabetes)
History of thyroid dysfunction in which the participant has not been on a stable dose (at least 6 weeks prior to enrollment) of thyroid replacement medication or antithyroid drugs.
History of cancer within the last 5 years (skin cancers, with the exception of melanoma, may be acceptable).
History of organ transplant
History of HIV, active Hepatitis B or C, or Tuberculosis
Pregnancy, lactation or 6 months postpartum from the scheduled date of collection
Psychiatric disease prohibiting adherence to study protocol
Use of oral or injectable anti-hyperglycemic agents: metformin, sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, thiazolidinediones, acarbose, GLP-1 analogs.
Use of any other medications known to influence glucose, fat and/or energy metabolism within the last 3 months (e.g., growth hormone therapy, glucocorticoids [steroids], prescribed medications for weight loss, etc.)
Presence of any condition that, in the opinion of the Investigator, compromises participant safety or data integrity or the participant's ability to complete study visits