Diabetes Mellitus Clinical Trial
— RADIANTOfficial title:
Rare and Atypical Diabetes Network
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.
Status | Recruiting |
Enrollment | 2000 |
Est. completion date | September 2030 |
Est. primary completion date | September 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
United States | University of Colorado- Denver | Aurora | Colorado |
United States | University of Maryland | Baltimore | Maryland |
United States | Massachusetts General Hospital (MGH) | Boston | Massachusetts |
United States | SUNY Downstate Health Sciences University | Brooklyn | New York |
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
United States | University of Chicago | Chicago | Illinois |
United States | Baylor College of Medicine | Houston | Texas |
United States | Indiana University | Indianapolis | Indiana |
United States | Vanderbilt University | Nashville | Tennessee |
United States | Columbia University | New York | New York |
United States | Washington University in St. Louis | Saint Louis | Missouri |
United States | Seattle Children's | Seattle | Washington |
United States | University of Washington | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of South Florida | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Phenotypic and genotypic characterization of previously unknown forms of diabetes using Whole Genome Sequencing (WGS), and deeper phenotyping methods | Deeper phenotyping methods include both clinical and laboratory assessments. Clinical data includes anthropometric and biometric data, medical histories, and standard questionnaires (ASA24, PROMIS, environmental exposures depression and anxiety). Laboratory data includes WGS, transcriptomics, metabolomics, mitochondrial sequencing, Oral Glucose Tolerance Test (OGTT), and Islet autoantibodies. Clustering methods will be used to define cohorts of similar diabetes genotypes and phenotypes based on this data. | Through study completion, an average of 3 years. |
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