Status:
ACTIVE_NOT_RECRUITING
REsearching Covid-19 Outcomes in Diabetes (RECODE)
Lead Sponsor:
AdventHealth Translational Research Institute
Conditions:
Covid19
Diabetes
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to observe any changes that may occur to certain organs following a confirmed diagnosis of COVID-19 in people with and without diabetes.
Eligibility Criteria
Inclusion
- For Type 2 Diabetes (T2D)
- Male or female 18 years of age and older willing and able to give informed consent to participate in the study
- Confirmed diagnosis of SARS-CoV-2 RNA via a polymerase chain reaction (PCR) assay (having been discharged at least 2 months from hospital but not greater than 6 months).
- Diagnosis of T2D according to American Diabetes Association (ADA) criteria.
- Must have access to a computer/laptop or a modern (no more than 3-4 years old) smart phone/tablet for cognitive assessments.
- For participant without Type 2 Diabetes (T2D)
- Male or female 18 years of age and older willing and able to give informed consent to participate in the study
- Confirmed diagnosis of SARS-CoV-2 RNA via a polymerase chain reaction (PCR) assay (having been discharged at least 2 months from hospital but not greater than 6 months).
- Must have access to a computer/laptop or a modern (no more than 3-4 years old) smart phone/tablet for cognitive assessments.
Exclusion
- Symptoms of active respiratory viral infection:
- high temperature (over 37.8°C/100.4°F)
- cough (consistent for over an hour; 3 or more episodes in 24 hours)
- Any history of Type I diabetes
- The participant may not enter the study with any known contraindication to magnetic resonance imaging including
- Pregnancy, lactation or 6 months postpartum from the scheduled date of collection
- Metal implants (pacemaker, aneurysm clips) based on Investigator's judgment at Screening
- Unable to participate in MRI assessments due to physical limitations of equipment tolerances (e.g. MRI bore size) based on Investigator's judgment at Screening
- Unable to tolerate MRI imaging or claustrophobia
- Any condition, including a significant underlying disease or disorder which, in the opinion of the investigator, may put the participant at risk by participating in the study or limit the participant's ability to participate.
Key Trial Info
Start Date :
March 24 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04805970
Start Date
March 24 2021
End Date
December 1 2025
Last Update
March 13 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
AdventHealth Translational Research Institute
Orlando, Florida, United States, 32804