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

Active, not recruiting

• Conditions: Type 1 Diabetes

• Registration Number: NCT04164966
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-13
• Study First Submitted QC: 2019-11-13
• Study First Posted: 2019-11-15
• Study Start: 2019-11-27
• Primary Completion: 2024-07-23
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-25
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

AdventHealth Translational Research Institute; 🇺🇸 Orlando, Florida, United States