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

Sponsor
AdventHealth Translational Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT04164966
Collaborator
(none)
20
Enrollment
1
Location
35.2
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Development of Novel Biomarkers for the Early Diagnosis of Type 1 Diabetes
    Actual Study Start Date :
    Nov 27, 2019
    Anticipated Primary Completion Date :
    Nov 1, 2022
    Anticipated Study Completion Date :
    Nov 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    New onset Type 1 Diabetes
    Healthy Normal Volunteers (HNV)

    Outcome Measures

    Primary Outcome Measures

    1. Characterization of circulating β cell-specific exosomes in children with T1D and healthy normal controls using baseline samples [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    Type 1 Diabetes (T1D)

    1. Age 12-18 years inclusive

    2. Diagnosis of T1D according to American Diabetes Association (ADA) criteria with an acute 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 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 or secondary diabetes)

    3. 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.

    4. History of cancer within the last 5 years (skin cancers, with the exception of melanoma, 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-4 inhibitors, SGLT2 inhibitors, thiazolidinediones, acarbose, GLP-1 analogs.

    10. 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.)

    11. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AdventHealth Translational Research Institute Orlando Florida United States 32804

    Sponsors and Collaborators

    • AdventHealth Translational Research Institute

    Investigators

    • Principal Investigator: Richard Pratley, MD, Study principal investigator

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    AdventHealth Translational Research Institute
    ClinicalTrials.gov Identifier:
    NCT04164966
    Other Study ID Numbers:
    • 1459977
    First Posted:
    Nov 15, 2019
    Last Update Posted:
    Feb 16, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 1

    Study Results

    No Results Posted as of Feb 16, 2022