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NCT05200819 · ClinicalTrials.gov registry record
Incidence and Predictors of Acute and Chronic Complications in Patients With Diabetes and Severe COVID-19
A clinical trial of COVID-19 and Diabetes Mellitus, sponsored by University of Michigan.
- Completed
- Registry status
- 70
- Enrollment target
- 1
- Study location
NCT05200819: Completed study of COVID-19 and Diabetes Mellitus, sponsored by University of Michigan.
NCT05200819 is a study of COVID-19 and Diabetes Mellitus that has completed, run by University of Michigan. The registered enrollment target is 70 participants, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05200819, a study of COVID-19 and Diabetes Mellitus, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
All surviving patients of the Michigan Medicine COVID-19 Cohort (M2C2, PI: Hayek) that were admitted to the University of Michigan for severe COVID-19 disease are eligible for this study. Investigators had prior approval from the Institutional Review Board (IRB) to collect the baseline blood and urine samples of these participants. Initial analysis on those samples are ongoing. In preliminary analysis of these patients a significantly higher risk for severe acute complications in patients with diabetes compared to those without diabetes was observed. The study will also enroll people following documented COVID-19 infection, regardless of whether or not they were hospitalized. The goal of the study is to understand what drives the increased risk of severe acute COVID-19 complications as well as to understand the long term sequelae of COVID-19 infection in patients with diabetes. The objectives of this study are to invite surviving M2C2 participants as well as others who have survived COVID-19 infection for an in-person visit, to measure biomarkers of inflammation and kidney, nerves, heart and blood vessels damage. participants will also be comprehensively phenotyped for diabetic complications outcomes, diabetes kidney disease, diabetes neuropathy and cardiovascular disease. Participants will be asked to fill out questionnaires to assess psychosocial metrics. The rationale is that correlating markers of acute hyperinflammation (cytokine storm syndrome) at admission in diabetes patients can inform vigilance and care for long term complications in survivors. Completing these studies will generate evidence-based guidelines for mitigating sequelae in diabetes COVID-19 survivors and identify critical psychosocial factors to mitigate psychological harm.
Primary Outcome
Comprehensively phenotype COVID-19 survivors for vascular outcomes including kidney disease, peripheral and autonomic neuropathy, cardiovascular disease, as well as cognitive disorders and and patient-reported outcomes.
Conditions Studied
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2020-12-02 |
| Est. Completion | 2023-02-20 |
What the finished NCT05200819 record still lists
NCT05200819 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with COVID-19 appearing as the primary indexed condition, and to 0 interventions.
NCT05200819 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT05200819 about?
NCT05200819 is a clinical study titled "Incidence and Predictors of Acute and Chronic Complications in Patients With Diabetes and Severe COVID-19". All surviving patients of the Michigan Medicine COVID-19 Cohort (M2C2, PI: Hayek) that were admitted to the University of Michigan for severe COVID-19 disease are eligible for this study. Investigators had prior approval from the Institutional Review Board (IRB) to collect the baseline blood and uri...
What is the current status of trial NCT05200819?
This trial is currently completed. The enrollment target is 70 participants. The study started on 2020-12-02. Estimated completion is 2023-02-20.
What conditions does trial NCT05200819 study?
This clinical trial studies the following conditions: COVID-19, Diabetes Mellitus.
Who is sponsoring clinical trial NCT05200819?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05200819 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05200819's enrollment target sits among peer trials
70 228th of 298 higher than 69 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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