Incidence and Predictors of Acute and Chronic Complications in Patients With Diabetes and Severe COVID-19

NCT05200819 | Completed

• 1 other identifier: HUM00186076
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Covid19; Diabetes Mellitus

Keywords

Covid19; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Risk-marker signatures for severe COVID-19 disease, longer-term complications in patients surviving COVID-19.

  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.

  Single visit lasting 2 to 6 hours. Visit will occur within 3 years of COVID-19 diagnosis

Study Arms (1)

COVID 19 Patients

Patients who have survived COVID-19 infection, including those included in the Michigan Medicine COVID-19 Cohort (M2C2) will be eligible to participate.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Living patients who were hospitalized for COVID-19 infection (Michigan Medicine COVID-19 or M2C2 Cohort) will be invited to participate in this study. In addition, any patient who has survived COVID-19 infection (regardless of whether they were hospitalized) may be enrolled.

You may not qualify if:

• Women who are currently pregnant or breastfeeding

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48105, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and Urine

MeSH Terms

Conditions

COVID-19; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Rodica Pop-Busui, M.D., Ph.D

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine Metabolism, Endocrinology and Diabetes Vice Chair of Clinical Research Department of Internal Medicine Associate Director, Clinical Research, Mentoring and Development, Elizabeth Weiser Caswell Diabetes Institute

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: January 21, 2022
• Study Start: December 2, 2020
• Primary Completion: February 20, 2023
• Study Completion: February 20, 2023
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)