REsearching Covid-19 Outcomes in Diabetes (RECODE)

NCT04805970 | Active Not Recruiting

• 1 other identifier: 1605203
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Diabetes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AdventHealth Translational Research Institute: lead

Study Sites (1)

AdventHealth Translational Research Institute

Orlando, Florida, 32804, United States

Location

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

• Richard Pratley, MD

  AdventHealth Orlando

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 18, 2021
• Study Start: March 24, 2021
• Primary Completion: October 22, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (1)