Clinical trial NCT04164966: Development of Novel Biomarkers for the Early Diagnosis of Type 1 Diabetes
Official title: Development of Novel Biomarkers for the Early Diagnosis of Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Type 1 Diabetes
Lead sponsor: AdventHealth Translational Research Institute
Sponsor class: OTHER
First posted: 2019-11-15
Enrollment: 28
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Characterization of circulating β cell-specific exosomes in children with T1D and healthy normal controls using baseline samples
timeFrame: 2-3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: AdventHealth Translational Research Institute
state: Florida
Study officials:
affiliation: Study principal investigator
name: Richard Pratley, MD
role: PRINCIPAL_INVESTIGATOR
References:
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