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REsearching Covid-19 Outcomes in Diabetes (RECODE)

Sponsor
AdventHealth Translational Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT04805970
Collaborator
(none)
66
Enrollment
1
Location
21.3
Anticipated Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    66 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    REsearching Covid-19 Outcomes in Diabetes (RECODE)
    Actual Study Start Date :
    Mar 24, 2021
    Anticipated Primary Completion Date :
    Jan 1, 2023
    Anticipated Study Completion Date :
    Jan 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with and without diabetes who were previously diagnosed with COVID-19

    Outcome Measures

    Primary Outcome Measures

    1. Measure and characterize organ volume change in patients with and without diabetes through use of summary statistics. [1 year]

      Patients recovering from the COVID-19 disease

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    For Type 2 Diabetes (T2D)

    1. Male or female 18 years of age and older willing and able to give informed consent to participate in the study

    2. 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).

    3. Diagnosis of T2D according to American Diabetes Association (ADA) criteria.

    4. 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)

    1. Male or female 18 years of age and older willing and able to give informed consent to participate in the study

    2. 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).

    3. Must have access to a computer/laptop or a modern (no more than 3-4 years old) smart phone/tablet for cognitive assessments.

    Exclusion Criteria:

    1. Symptoms of active respiratory viral infection:

    2. high temperature (over 37.8°C/100.4°F)

    3. cough (consistent for over an hour; 3 or more episodes in 24 hours)

    4. Any history of Type I diabetes

    5. The participant may not enter the study with any known contraindication to magnetic resonance imaging including

    6. Pregnancy, lactation or 6 months postpartum from the scheduled date of collection

    7. Metal implants (pacemaker, aneurysm clips) based on Investigator's judgment at Screening

    8. 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

    9. Unable to tolerate MRI imaging or claustrophobia

    10. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AdventHealth Translational Research Institute Orlando Florida United States 32804

    Sponsors and Collaborators

    • AdventHealth Translational Research Institute

    Investigators

    • Principal Investigator: Richard Pratley, MD, AdventHealth Orlando

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AdventHealth Translational Research Institute
    ClinicalTrials.gov Identifier:
    NCT04805970
    Other Study ID Numbers:
    • 1605203
    First Posted:
    Mar 18, 2021
    Last Update Posted:
    Apr 14, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19
    Diabetes Mellitus

    Study Results

    No Results Posted as of Apr 14, 2022