Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:33 PM
Ignite Modification Date:
2025-12-24 @ 4:33 PM
NCT ID:
NCT05544266
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
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05544266
Study Brief:
Protocol Section:
NCT05544266