REsearching Covid-19 Outcomes in Diabetes (RECODE)

Active, not recruiting

• Conditions: Diabetes; Covid19

• Registration Number: NCT04805970
• Lead Sponsor: AdventHealth Translational Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-17
• Study First Submitted QC: 2021-03-17
• Study First Posted: 2021-03-18
• Study Start: 2021-03-24
• Primary Completion: 2024-10-22
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-13
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

AdventHealth Translational Research Institute; 🇺🇸 Orlando, Florida, United States