Background: There are mixed data on whether COVID-19 infection is associated with increased incidence of type 2 diabetes (T2DM). The majority of data have been derived from retrospective datasets. We sought to identify predictors of new onset T2DM in a prospective cohort enrolled in the multi-site phase 3 randomized quadruple-blinded placebo-controlled COVID-OUT clinical trial.
Methods: Adults with overweight or obesity aged 30-85 were enrolled within 3 days of a positive SARS-CoV-2 test and <7 days of symptoms. Participants were randomized to 1 or 2 of 3 oral medications (immediate-release metformin increasing over 6 days to 1500 mg daily for a total of 14 days; ivermectin 430mcg/kg/day for 3 days; fluvoxamine 50mg day 1 then 50mg twice daily through 14 days) or placebo using a two by three parallel treatment factorial design. Starting 60 days after randomization we sent automated email surveys every 30 days through 300 days about new diabetes diagnoses, as well as changes in weight and sleep. We conducted univariable analyses to determine predictors of T2DM diagnosis.
Results: Among 1093 subjects, 25 reported a new diagnosis of diabetes within 300 days of COVID-19 infection. There were no significant differences in incidence by treatment arm or vaccination in univariate analysis. Participants with new onset T2DM had a higher baseline BMI (OR 1.08, 95% CI 1.03 to 1.13), and were more likely to report weight gain between the start of the pandemic and their first infection and more likely to report difficulty sleeping, OR 1.04 (95% CI 1.01 to 1.07) and OR 2.86 (95% CI 1.16 to 7.06), respectively. Multivariate analysis is pending.
Conclusions: Patients with higher BMIs at baseline, those who gained weight between the onset of the pandemic and their first COVID-19 infection, or had difficulty sleeping were more likely to develop T2DM. Covid treatment with metformin, ivermectin, and fluvoxamine and vaccination status were not significant predictors of new T2DM.
J.M.Nicklas: None. E.J.Lemus wirtz: None. T.A.Murray: None. D.Liebovitz: None. S.Fenno: None. B.Anderson: None. N.Avula: None. N.Reddy: None. C.Bramante: None.
Rainwater Foundation; Parsemus Foundation; United Health Foundation; National Center for Advancing Translational Sciences (KL2TR002492, UL1TR002494); National Institute of Diabetes and Digestive and Kidney Diseases (K23DK124654-01-A1); National Heart, Lung, and Blood Institute (K23HL133604)