REsearching Covid-19 Outcomes in Diabetes (RECODE) (RECODE)

March 25, 2026 updated by: AdventHealth Translational Research Institute
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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32804
        • AdventHealth Translational Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients who were initially hospitalized with laboratory-confirmed SARS-CoV-2 infection [COVID-19 disease], who are no-longer considered infectious by approved bioassay

Description

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:

    1. high temperature (over 37.8°C/100.4°F)
    2. cough (consistent for over an hour; 3 or more episodes in 24 hours)
  2. Any history of Type I diabetes

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

    1. Pregnancy, lactation or 6 months postpartum from the scheduled date of collection
    2. Metal implants (pacemaker, aneurysm clips) based on Investigator's judgment at Screening
    3. 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
    4. Unable to tolerate MRI imaging or claustrophobia
  4. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with and without diabetes who were previously diagnosed with COVID-19

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure and characterize organ volume change in patients with and without diabetes through use of summary statistics.
Time Frame: 1 year
Patients recovering from the COVID-19 disease
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth Translational Research Institute

Investigators

  • Principal Investigator: Richard Pratley, MD, AdventHealth Orlando

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2021

Primary Completion (Actual)

October 22, 2024

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 17, 2021

First Submitted That Met QC Criteria

March 17, 2021

First Posted (Actual)

March 18, 2021

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1605203

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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