Recruiting

Observational StudyRare and Atypical Diabetes Network

Sponsor:

University of South Florida

Code:

NCT05544266

Conditions

Diabetes Mellitus

Diabetes Mellitus Progression

Glucose Intolerance

Glucose Metabolism Disorders

Metabolic Disease

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Diabetes Mellitus

Diabetes Mellitus Progression

Glucose Intolerance

Glucose Metabolism Disorders

Metabolic Disease

Study ID

NCT05544266

Start date

Sep 30, 2020

Status verified date

Aug, 2025

Completion date

Sep, 2030

Anticipated

Primary completion date

Sep, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

Phenotypic and genotypic characterization of previously unknown forms of diabetes using Whole Genome Sequencing (WGS), and deeper phenotyping methods [ Time Frame: Through study completion, an average of 3 years. ]

Central Contacts and Locations

Central contacts

Jeffrey Krischer, PhD

813-396-9501 contact@atypicaldiabetesnetwork.org

Locations

University of Colorado- Denver

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Marjan Rezaei

303-724-1290 marjan.rezaei@cuanschutz.edu

Principal Investigator:

Neda Rasouli, MD

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Lisa Letourneau

773-702-0829 radiant@uchicago.edu

Principal Investigator:

Lou Philipson, MD, PhD

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Sarah Fischer

317-278-7042 hollowas@iu.edu

Principal Investigator:

Carmella Evans-Molina, MD, PhD

University of Maryland

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Cindi Young

410-979-4322 cyoung2@som.umaryland.edu

Principal Investigator:

Toni Pollin, PhD, MS

Massachusetts General Hospital (MGH)

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Julia Douvas

617-724-3954 MGHRADIANTStudy@partners.org

Principal Investigator:

Sara Cromer, MD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Adam Neidert

734-615-0539 aneidert@med.umich.edu

Principal Investigator:

Elif Oral, MD

Washington University in St. Louis

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Stacy Hurst

314-747-3294 shurst@wustl.edu

Brittany Zsijack

314-747-8251 bzwijack@wustl.edu

Principal Investigator:

Fumihiko Urano, MD, PhD

SUNY Downstate Health Sciences University

Recruiting

Brooklyn, New York, United States, 11203

Contacts

Necole Brown

718-270-4693 necole.brown01@downstate.edu

Principal Investigator:

Mary Ann Banerji, MD

Columbia University

Recruiting

New York, New York, United States, 10032

Contacts

Kaisha Mofford

212-851-5512 berrietrials@cumc.columbia.edu

Principal Investigator:

Robin Goland, MD

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Rachel Unger

984-974-3011 RADIANT@med.unc.edu

Principal Investigator:

John Buse, MD, PhD

Vanderbilt University

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Norma Edwards

615-403-8937 radiant@vumc.org

Principal Investigator:

Kevin Niswender, MD, PhD

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Molly Wahlquist

791-798-5757 radiantstudy@bcm.edu

Principal Investigator:

Ashok Balasubramanyam, MD

University of Washington

Recruiting

Seattle, Washington, United States, 98109

Contacts

Dori Khakpour

206-616-1354 dorik@uw.edu

Principal Investigator:

Irl B Hirsch, MD

More Information

Sponsor

University of South Florida

Last update posted

Aug 14, 2025

Last verified

Aug, 2025

Keywords

RADIANT
Atypical Diabetes
Rare Diabetes
Glucose Intolerance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of South Florida on 2025-08-14.