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

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: Diabetes; Covid19

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

1

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.	Patients recovering from the COVID-19 disease	1 year

Collaborators and Investigators

• Sponsor: AdventHealth Translational Research Institute
• Investigators: Principal Investigator: Richard Pratley, MD, AdventHealth Orlando

Study record dates

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: Endocrine System Diseases; Metabolic Diseases; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Glucose Metabolism Disorders; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Nutritional and Metabolic Diseases; COVID-19; Diabetes Mellitus
• 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