Development of Novel Biomarkers for the Early Diagnosis of Type 1 Diabetes

Last updated: March 12, 2025
Sponsor: AdventHealth Translational Research Institute
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Diabetes Mellitus, Type 1

Diabetes Mellitus Types I And Ii

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT04164966
1459977
  • Ages 12-18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Type 1 Diabetes (T1D)

  1. Age 12-18 years inclusive

  2. Diagnosis of T1D according to American Diabetes Association (ADA) criteria with anacute onset and presence of islet associated autoantibody by history.

  3. T1D duration of ≤ 3 months from the diagnosis

Healthy Normal Volunteers (HNV)

  1. Age 12-18 years inclusive

  2. No personal history of diabetes according to ADA criteria

  3. 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:

  1. History of type 2 diabetes

  2. Suspicion of non-type 1 diabetes (e.g. maturity onset diabetes of the young orsecondary diabetes)

  3. 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.

  4. History of cancer within the last 5 years (skin cancers, with the exception ofmelanoma, may be acceptable).

  5. History of organ transplant

  6. History of HIV, active Hepatitis B or C, or Tuberculosis

  7. Pregnancy, lactation or 6 months postpartum from the scheduled date of collection

  8. Psychiatric disease prohibiting adherence to study protocol

  9. Use of oral or injectable anti-hyperglycemic agents: metformin, sulfonylureas, DPP-4inhibitors, SGLT2 inhibitors, thiazolidinediones, acarbose, GLP-1 analogs.

  10. 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.)

  11. 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

Total Participants: 28
Study Start date:
November 27, 2019
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • AdventHealth Translational Research Institute

    Orlando, Florida 32804
    United States

    Site Not Available

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