| NCT ID | NCT05544266 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of South Florida |
| Condition | Diabetes Mellitus |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2020-09-30 |
| Primary Completion | 2030-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2020-09-30 with a primary completion date of 2030-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
RADIANT is a network of 14 clinical sites and several laboratories dedicated to the study of atypical diabetes. The objective of this study is to define new forms of diabetes and the unique mechanisms underlying these forms of atypical diabetes. The specific aims are to: 1. Identify and enroll individuals and families with undiagnosed rare and atypical forms of diabetes. 2. Determine the etiologic basis of the metabolic disorder among individuals and families with novel forms of rare and atypical diabetes. 3. Understand the pathophysiology of individuals and families with novel forms of rare and atypical forms of diabetes.
Eligibility Criteria
Inclusion Criteria: The following criteria or phenotypes will be considered for suspecting "atypical" participants: * Type 2 diabetes diagnosed at a time when the individual was prepubertal or non-obese * Mendelian pattern, especially with early onset (\<18 years old) * Syndromic (multiple systems involved) * Lipodystrophic * Extremes of BMI * "Mitochondrial" characteristics (e.g., myopathy, hearing deficits) * Non-progressive * Rapidly progressive ("fulminant") * Low insulin requirements (\<0.5 u/kg/day) * Cyclical hyperglycemia with periods of remission * Lean persons with polycystic ovarian syndrome (PCOS) * History of gestational diabetes (GDM) when lean * Lean insulin-resistant persons * If islet autoantibodies and beta-cell function parameters have been measured (where "A" = islet cell autoantibodies, "B" = beta-cell function): oA-B- (i.e., lacking islet autoimmunity makers and lacking beta cell function) oA-B+ with unprovoked DKA at initial presentation (i.e., lacking islet autoimmune markers, with preserved beta-cell function, but presenting with unprovoked DKA) oA-B+ of very young onset (pre-pubertal) (i.e., lacking islet autoimmune markers, with preserved beta-cell function, but very early onset T2D-like phenotype) Exclusion Criteria: * Those with high likelihood of typical type 1, typical type 2, known monogenic, or other known secondary forms of diabetes * Refusal of consent for genetic testing * Islet autoantibody positive (participants who are islet autoantibody positive but present with additional atypical features i.e. syndromic, strong linear family history of diabetes may not be excluded) * Women who are currently pregnant
Contact & Investigator
Jeffrey Krischer, PhD
STUDY CHAIR
University of South Florida
Frequently Asked Questions
Who can join the NCT05544266 clinical trial?
This trial is open to participants of all sexes, studying Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05544266 currently recruiting?
Yes, NCT05544266 is actively recruiting participants. Contact the research team at contact@atypicaldiabetesnetwork.org for enrollment information.
Where is the NCT05544266 trial being conducted?
This trial is being conducted at Aurora, United States, Chicago, United States, Indianapolis, United States, Baltimore, United States and 9 additional locations.
Who is sponsoring the NCT05544266 clinical trial?
NCT05544266 is sponsored by University of South Florida. The principal investigator is Jeffrey Krischer, PhD at University of South Florida. The trial plans to enroll 2,000 participants.
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