Several studies have found that infection with SARS-CoV-2 and a COVID-19 diagnosis are associated with a higher risk for the development and progression of both Type 1 and Type 2 diabetes, possibly through the infection of insulin-secreting beta cells, increased insulin resistance, inflammation and fibrosis and other biological processes.
The COVID-19 and Diabetes Assessment (CODA) Study will identify and recruit 1,600 participants through the T1D Exchange, a research network of diabetes centers, and , a national research network funded by the Patient-Centered Outcomes Research Institute, which engages hundreds of health care sites with access to electronic health record data from more than 30 million patients annually.
People with a known COVID-19 infection within the past 90 days and who also have been diagnosed with diabetes during that period will be compared to those with a recent diabetes diagnosis who have no known COVID-19 infection in the past year. Study participants will be followed for two years.
CODA’s goal is to gain a deeper understanding of the link between COVID-19 and diabetes that can guide future treatment interventions and public health approaches. CODA will be led by a team of investigators with significant experience in treating COVID-19, obesity and diabetes in children and adults.
“This study will greatly expand our knowledge about the relationship between COVID-19 and diabetes and will also provide us novel information about what factors influence the early course of diabetes in children and adults with Type 1 or Type 2 diabetes,” said principal investigator and project leader Russell Rothman, MD, MPP.
Rothman, the Ingram Professor of Integrative and Population Health and professor of Internal Medicine, Pediatrics, and Health Policy at Vanderbilt, is also VUMC Senior Vice President for Population and Public Health, and director of the Vanderbilt Institute for Medicine and Public Health.
Co-principal investigators are:
- Alvin Powers, MD, the Joe C. Davis Professor of Biomedical Science, professor of Medicine and of Molecular Physiology and Biophysics, director of the Vanderbilt Diabetes Center and of the Vanderbilt Diabetes Research and Training Center, and chief of the Division of Diabetes, Endocrinology and Metabolism.
- Jonathan Schildcrout, PhD, professor of Biostatistics and Anesthesiology at VUMC.
- Jason Block, MD, MPH, associate professor of Population Health in the Harvard Pilgrim Health Care Institute.
Diabetes is characterized by high levels of blood glucose, which increase the risk for heart and kidney disease, nerve and eye damage, and other serious complications. The disease results from the body’s inability to make or respond to insulin, a hormone that promotes glucose uptake by the tissues.
Type 1 diabetes, which usually is diagnosed in children, results from destruction of the beta cells of the pancreas. Type 2 diabetes is the most common form of the disease. It usually develops later in life and occurs when body tissues do not respond (become resistant) to insulin.
CODA will explore:
- Whether participants diagnosed with COVID-19 who developed Type 2 diabetes, both within 90 days, are more likely to have worse control over their blood glucose levels, increased inflammation, and increased insulin resistance than patients with Type 2 diabetes but without a recent COVID-19 diagnosis.
- Whether participants with recent diagnoses of both COVID-19 and Type 1 diabetes are more likely to have worse glycemic control, increased inflammation and a more rapid reduction in the function of their beta cells than those without a recent COVID-19 diagnosis.
- Whether COVID-19 is associated with worse vascular function, increased inflammation, and hypercoagulability (increased tendency to form blood clots within blood vessels) in a subset of participants with diabetes.
- The role of genomic, social and environmental factors on inflammation and metabolic function.
- The impact of COVID-19 and COVID-19 treatments on the development of diabetes and on diabetes-related outcomes over the course of the pandemic.
Individuals who agree to participate in the study will be surveyed by phone, online or in person and will provide regular blood samples. A subset of participants will have glucose tolerance, biomarkers and vascular function testing. The study will also leverage longitudinal electronic health record data from participating sites and across .
The research was supported by1U01DK137533.
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