Phase
Condition
Diabetes Mellitus, Type 1
Diabetes Mellitus Types I And Ii
Diabetes Prevention
Treatment
N/AClinical Study ID
Ages 12-18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Type 1 Diabetes (T1D)
Age 12-18 years inclusive
Diagnosis of T1D according to American Diabetes Association (ADA) criteria with anacute 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)
Exclusion
Exclusion Criteria:
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 orsecondary diabetes)
History of thyroid dysfunction in which the participant has not been on a stabledose (at least 6 weeks prior to enrollment) of thyroid replacement medication orantithyroid drugs.
History of cancer within the last 5 years (skin cancers, with the exception ofmelanoma, 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-4inhibitors, SGLT2 inhibitors, thiazolidinediones, acarbose, GLP-1 analogs.
Use of any other medications known to influence glucose, fat and/or energymetabolism 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, compromisesparticipant safety or data integrity or the participant's ability to complete studyvisits
Study Design
Connect with a study center
AdventHealth Translational Research Institute
Orlando, Florida 32804
United StatesSite Not Available
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