NIH – Understanding the Pathophysiology and Clinical Course of New-Onset Diabetes Following COVID-19 (U01 Clinical Trial Not Allowed)

July 22, 2022 by


This Funding Opportunity Announcement invites multiple Program Director/Principal Investigator (multi-PD/PI) applications to conduct a study to establish a longitudinal cohort of individuals who developed diabetes following SARS-CoV-2 infection to understand the pathophysiology and clinical course post-COVID-19 diabetes. The cohort must include children and adults and reflect the geography and demographics of COVID-19 in the U.S. There must be an appropriate comparator population recruited and followed. The goals are to determine the contribution of: 1) specific pathophysiologic pathways; 2) overall health impact of the pandemic; 3) COVID-19 severity, and 4) COVID-19 treatment upon excess new onset diabetes from SARS-CoV-2 infection and response to diabetes therapy.


Emerging epidemiologic evidence world-wide suggests worrisome increases in the incidence of diabetes in both adults and children following SARS-CoV-2 infection. Increasing rates have been reported for both type 1 and type 2 diabetes; however, often the type or characteristics of the diabetes have not been well described. Emerging evidence suggests that there may be direct viral-mediated increases in diabetes, given cadaveric studies demonstrating SARS-CoV-2 infection of pancreatic beta cells. Development of hyperglycemia during acute infection could also be due to physiologic stress, systemic inflammation, or COVID-19 treatment, including glucocorticoids. Other pandemic-related factors may be contributing to development of diabetes. For instance, adults and children have gained weight and physical activity has decreased during the pandemic. Rates of poor mental health, including depression, and anxiety have increased. Elevated psychosocial stress is associated with metabolic disease potentially through direct (e.g., elevated systemic inflammation) and indirect mechanisms (e.g., suboptimal lifestyle habits such as sleep and physical activity). Additionally, individuals with post-COVID-19 incident diabetes may have had it previously but have been undiagnosed, been predisposed or at risk to developing diabetes prior to acute COVID-19 and other pandemic insults, and this increased incidence may reflect accelerated onset or an unmasking of pre-diabetes. Many of these indirect pandemic factors are also likely root contributors to racial and ethnic disparities in metabolic health surrounding COVID-19. Research is needed to comprehensively characterize the onset, clinical course, and physiology of new-onset diabetes after COVID-19, and the relationships among predisposing factors, SARS-CoV-2 infection, and diabetes.

Key Dates:

Open Date (Earliest Submission Date): November 20, 2022
Letter of Intent Due Date(s): November 20, 2022
Applications Due: December 20, 2022

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Filed Under: Funding Opportunities