Network for studying rare and atypical diabetes
Rare and Atypical Diabetes Network
This study is trying to find and understand rare types of diabetes by testing people and families who haven't been diagnosed yet, using blood tests and genetic screening to learn more about these conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Sex | All |
| Sponsor | University of South Florida Academic / other |
| Locations | 13 sites (Aurora, Colorado and 12 other locations) |
| Trial ID | NCT05544266 on ClinicalTrials.gov |
What this trial studies
RADIANT is a collaborative network involving 14 clinical sites and laboratories focused on identifying and understanding atypical forms of diabetes. The study aims to enroll individuals and families with undiagnosed rare diabetes, investigate the underlying mechanisms, and perform genetic screening and deeper phenotyping. Participants will undergo a series of assessments, including questionnaires, blood tests, and whole genome sequencing, to uncover novel forms of diabetes and their etiologies.
Who should consider this trial
Good fit: Ideal candidates include individuals with atypical diabetes characteristics, such as early-onset type 2 diabetes or syndromic forms of diabetes.
Not a fit: Patients with common forms of diabetes that do not exhibit atypical characteristics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better diagnosis and treatment options for individuals with rare and atypical forms of diabetes.
How similar studies have performed: While the study's approach is novel in its focus on atypical diabetes, similar studies have shown promise in understanding rare metabolic disorders.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aurora, Colorado and 12 other locations
- University of Colorado- Denver — Aurora, Colorado, United States (Recruiting)
- University of Chicago — Chicago, Illinois, United States (Recruiting)
- Indiana University — Indianapolis, Indiana, United States (Recruiting)
- University of Maryland — Baltimore, Maryland, United States (Recruiting)
- Massachusetts General Hospital (MGH) — Boston, Massachusetts, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- Washington University in St. Louis — St Louis, Missouri, United States (Recruiting)
- SUNY Downstate Health Sciences University — Brooklyn, New York, United States (Recruiting)
- Columbia University — New York, New York, United States (Recruiting)
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
- Vanderbilt University — Nashville, Tennessee, United States (Recruiting)
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
- University of Washington — Seattle, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Jeffrey Krischer, PhD
- Email: contact@atypicaldiabetesnetwork.org
- Phone: 813-396-9501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.