NCT05544266

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. 1.Identify and enroll individuals and families with undiagnosed rare and atypical forms of diabetes.
  2. 2.Determine the etiologic basis of the metabolic disorder among individuals and families with novel forms of rare and atypical diabetes.
  3. 3.Understand the pathophysiology of individuals and families with novel forms of rare and atypical forms of diabetes.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
53mo left

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
1 country

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Sep 2020Sep 2030

Study Start

First participant enrolled

September 30, 2020

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2030

Last Updated

August 14, 2025

Status Verified

August 1, 2025

Enrollment Period

9.9 years

First QC Date

August 23, 2022

Last Update Submit

August 11, 2025

Conditions

Keywords

RADIANTAtypical DiabetesRare DiabetesGlucose Intolerance

Outcome Measures

Primary Outcomes (1)

  • 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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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):
  • +1 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

University of Colorado- Denver

Aurora, Colorado, 80045, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

University of Maryland

Baltimore, Maryland, 21201, United States

RECRUITING

Massachusetts General Hospital (MGH)

Boston, Massachusetts, 02114, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Washington University in St. Louis

St Louis, Missouri, 63110, United States

RECRUITING

SUNY Downstate Health Sciences University

Brooklyn, New York, 11203, United States

RECRUITING

Columbia University

New York, New York, 10032, United States

RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

RECRUITING

Vanderbilt University

Nashville, Tennessee, 37232, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

University of Washington

Seattle, Washington, 98109, United States

RECRUITING

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood Serum Plasma DNA RNA Urine Peripheral Blood Monocytes (PBMCs)

MeSH Terms

Conditions

Diabetes MellitusGlucose IntoleranceGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesHyperglycemia

Study Officials

  • Jeffrey Krischer, PhD

    University of South Florida

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2022

First Posted

September 16, 2022

Study Start

September 30, 2020

Primary Completion (Estimated)

September 1, 2030

Study Completion (Estimated)

September 1, 2030

Last Updated

August 14, 2025

Record last verified: 2025-08

Locations