Diabetes MellitusRADIANTNCT05544266
Rare and Atypical Diabetes Network
An observational study of Diabetes Mellitus and Diabetes Mellitus Progression, run by University of South Florida at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Diabetes Mellitus Progression, Glucose Intolerance
- How many people
- 2,000 participants
- Where
- 13 sitesUnited States
- Study dates
- 30 Sep 2020to Sep 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Probands and family members will be screened for evaluation of suspected atypical diabetes of unknown origin. Among the pool of evaluated individuals, those found to have a known form of diabetes will be excluded from further study. The remaining participants will be prioritized for genetic/genomic analysis and further testing.
Who may be able to join
- 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
Show all 16Show fewer
- "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)
Who cannot join
- 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
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United States13 sites, 13 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Adam Neidert, 734-615-0539, aneidert@med.umich.edu
Elif Oral, MD
- Recruiting
University of Colorado- Denver
Aurora, Colorado, 80045
Marjan Rezaei, 303-724-1290, marjan.rezaei@cuanschutz.edu
Neda Rasouli, MD
- Recruiting
University of Maryland
Baltimore, Maryland, 21201
Cindi Young, 410-979-4322, cyoung2@som.umaryland.edu
Toni Pollin, PhD, MS
- Recruiting
Massachusetts General Hospital (MGH)
Boston, Massachusetts, 02114
Julia Douvas, 617-724-3954, MGHRADIANTStudy@partners.org
Sara Cromer, MD
- Recruiting
SUNY Downstate Health Sciences University
Brooklyn, New York, 11203
Necole Brown, 718-270-4693, necole.brown01@downstate.edu
Mary Ann Banerji, MD
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Rachel Unger, 984-974-3011, RADIANT@med.unc.edu
John Buse, MD, PhD
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Lisa Letourneau, 773-702-0829, radiant@uchicago.edu
Lou Philipson, MD, PhD
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Molly Wahlquist, 791-798-5757, radiantstudy@bcm.edu
Ashok Balasubramanyam, MD
- Recruiting
Indiana University
Indianapolis, Indiana, 46202
Sarah Fischer, 317-278-7042, hollowas@iu.edu
Carmella Evans-Molina, MD, PhD
- Recruiting
Vanderbilt University
Nashville, Tennessee, 37232
Norma Edwards, 615-403-8937, radiant@vumc.org
Kevin Niswender, MD, PhD
- Recruiting
Columbia University
New York, New York, 10032
Kaisha Mofford, 212-851-5512, berrietrials@cumc.columbia.edu
Robin Goland, MD
- Recruiting
University of Washington
Seattle, Washington, 98109
Dori Khakpour, 206-616-1354, dorik@uw.edu
Irl B Hirsch, MD
- Recruiting
Washington University in St. Louis
St Louis, Missouri, 63110
Stacy Hurst, 314-747-3294, shurst@wustl.edu
Brittany Zsijack, 314-747-8251, bzwijack@wustl.edu
About this study
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:
- Identify and enroll individuals and families with undiagnosed rare and atypical forms of diabetes.
- Determine the etiologic basis of the metabolic disorder among individuals and families with novel forms of rare and atypical diabetes.
- Understand the pathophysiology of individuals and families with novel forms of rare and atypical forms of diabetes.
Read the detailed description
RADIANT has three distinct stages.
Stage 1:
Stage 1 participants will complete a consent form and a questionnaire to determine the potential for having atypical forms of diabetes. Participants identified as potentially atypical based on questionnaire responses will be asked to provide a blood sample to test for islet autoantibodies and complete additional questionnaires.
The RADIANT Adjudication Committee, which is comprised of a team of experts in diabetes, will assess the data collected in Stage 1 and select and prioritize participants to proceed to Stage 2 and 3 for Whole Genome Sequencing (WGS) and other testing.
Stage 2:
Stage 2 of the study includes genetic screening for known forms of monogenic diabetes. Participants will consent for this stage of the study, complete a family history questionnaire, and have blood collected for DNA and RNA extraction, storage, and analysis. WGS will be performed on all DNA samples. If no pathogenic/likely pathogenic variant in a known monogenic diabetes gene that is thought to explain the participant's diabetes is identified by WGS, RNA Sequencing will be performed at Baylor College of Medicine.
Stage 3:
Stage 3 of the study includes deeper phenotyping. All participants who proceed to Stage 3 will visit a study clinic to consent and complete Stage 3 Standard procedures which include: an Oral Glucose Tolerance Test (OGTT), additional blood collection, a detailed physical exam, and additional questionnaires.
Discovery Team Review:
The work of the Discovery Team is expected to be an iterative process analyzing all data collected up to this point in the study to understand the significance of novel variants. In some instances, the Discovery Team may determine that enrollment of the Proband's family members is necessary. Family members with suspected atypical diabetes will follow the same study procedures as described above. Affected and unaffected family members may also be enrolled for Sanger Sequencing. The Discovery Team may also recommend additional optional procedures to better characterize the participant's form of diabetes.
- Conditions
- Diabetes Mellitus, Diabetes Mellitus Progression, Glucose Intolerance, Glucose Metabolism Disorders, Metabolic Disease, Endocrine; Complications
- Keywords
- RADIANT, Atypical Diabetes, Rare Diabetes, Glucose Intolerance
- Medical subject headings
- Diabetes Mellitus, Glucose Intolerance, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start30 Sep 2020
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Krischer, PhD, Study chair, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544266
- Sponsor's protocol ID
- RADIANT
- Other IDs
- 5U54DK118638, 5U54DK118612
- Acronym
- RADIANT
- Status last verified
- Aug 2025
- First submitted
- 23 Aug 2022
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
RADIANT Study Group. The Rare and Atypical Diabetes Network (RADIANT) Study: Design and Early Results. Diabetes Care. 2023 Jun 1;46(6):1265-1270. doi: 10.2337/dc22-2440.
PubMed 37104866
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rare and Atypical Diabetes Network
- ClinicalTrials.gov ID
- NCT05544266
- Acronym / sponsor ID
- RADIANT / RADIANT
- Conditions
- Diabetes Mellitus, Diabetes Mellitus Progression, Glucose Intolerance, Glucose Metabolism Disorders, Metabolic Disease, Endocrine; Complications
- Keywords
- RADIANT, Atypical Diabetes, Rare Diabetes, Glucose Intolerance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Identify and enroll individuals and families with undiagnosed rare and atypical forms of diabetes.
- Determine the etiologic basis of the metabolic disorder among individuals and families with novel forms of rare and atypical diabetes.
- Understand the pathophysiology of individuals and families with novel forms of rare and atypical forms of diabetes.
Detailed description
RADIANT has three distinct stages.
Stage 1:
Stage 1 participants will complete a consent form and a questionnaire to determine the potential for having atypical forms of diabetes. Participants identified as potentially atypical based on questionnaire responses will be asked to provide a blood sample to test for islet autoantibodies and complete additional questionnaires.
The RADIANT Adjudication Committee, which is comprised of a team of experts in diabetes, will assess the data collected in Stage 1 and select and prioritize participants to proceed to Stage 2 and 3 for Whole Genome Sequencing (WGS) and other testing.
Stage 2:
Stage 2 of the study includes genetic screening for known forms of monogenic diabetes. Participants will consent for this stage of the study, complete a family history questionnaire, and have blood collected for DNA and RNA extraction, storage, and analysis. WGS will be performed on all DNA samples. If no pathogenic/likely pathogenic variant in a known monogenic diabetes gene that is thought to explain the participant's diabetes is identified by WGS, RNA Sequencing will be performed at Baylor College of Medicine.
Stage 3:
Stage 3 of the study includes deeper phenotyping. All participants who proceed to Stage 3 will visit a study clinic to consent and complete Stage 3 Standard procedures which include: an Oral Glucose Tolerance Test (OGTT), additional blood collection, a detailed physical exam, and additional questionnaires.
Discovery Team Review:
The work of the Discovery Team is expected to be an iterative process analyzing all data collected up to this point in the study to understand the significance of novel variants. In some instances, the Discovery Team may determine that enrollment of the Proband's family members is necessary. Family members with suspected atypical diabetes will follow the same study procedures as described above. Affected and unaffected family members may also be enrolled for Sanger Sequencing. The Discovery Team may also recommend additional optional procedures to better characterize the participant's form of diabetes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Probands and family members will be screened for evaluation of suspected atypical diabetes of unknown origin. Among the pool of evaluated individuals, those found to have a known form of diabetes will be excluded from further study. The remaining participants will be prioritized for genetic/genomic analysis and further testing.
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Derived from this study: PubMed 37104866RADIANT Study Group. The Rare and Atypical Diabetes Network (RADIANT) Study: Design and Early Results. Diabetes Care. 2023 Jun 1;46(6):1265-1270. doi: 10.2337/dc22-2440.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeffrey Krischer, PhD study chair
University of South Florida
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Diabetes Mellitus Progression, run by University of South Florida at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey Krischer, PhD (813-396-9501, contact@atypicaldiabetesnetwork.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05544266, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.