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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 Diabetes Mellitus and Covid19, sponsored by University of Michigan.

Completed
Registry status
70
Enrollment target
1
Study location

NCT05200819 is a study of Diabetes Mellitus and Covid19 that has completed, run by University of Michigan. The registered enrollment target is 70 participants, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05200819, a study of Diabetes Mellitus and Covid19, 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.

Study Locations (1)

Michigan

  • University of Michigan - Ann Arbor

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2020-12-02
Est. Completion 2023-02-20

Sponsor

University of Michigan

1,327 total trials

What the Registry Record Tells You About NCT05200819

The ClinicalTrials.gov registry entry for NCT05200819 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (96% lower). The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Diabetes Mellitus appearing as the primary indexed condition, and to 0 interventions.

NCT05200819 reports 1 study location spanning 1 distinct geographic area - top geographies include 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: Diabetes Mellitus, Covid19.

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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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