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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.
 
ClinicalTrials.gov Identifier: NCT04164966
Recruitment Status : Recruiting
First Posted : November 15, 2019
Last Update Posted : February 16, 2022
Sponsor:
Information provided by (Responsible Party):
AdventHealth Translational Research Institute

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
Type 1 Diabetes

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Study Type : Observational
Estimated 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 : November 27, 2019
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Group/Cohort
New onset Type 1 Diabetes
Healthy Normal Volunteers (HNV)



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04164966


Contacts
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Contact: Recruitment Department 407-303-7100 Fh.tri.recruitment@adventhealth.com

Locations
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United States, Florida
AdventHealth Translational Research Institute Recruiting
Orlando, Florida, United States, 32804
Contact: Recruitment Department    407-303-7100    Fh.tri.recruitment@adventhealth.com   
Sponsors and Collaborators
AdventHealth Translational Research Institute
Investigators
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Principal Investigator: Richard Pratley, MD Study principal investigator
Additional Information:
Publications:

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Responsible Party: AdventHealth Translational Research Institute
ClinicalTrials.gov Identifier: NCT04164966    
Other Study ID Numbers: 1459977
First Posted: November 15, 2019    Key Record Dates
Last Update Posted: February 16, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases