REsearching Covid-19 Outcomes in Diabetes (RECODE)

NCT ID: NCT04805970

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-24
• Study Completion Date: 2025-12-31

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AdventHealth Translational Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Pratley, MD

Role: PRINCIPAL_INVESTIGATOR

AdventHealth Orlando

Locations

AdventHealth Translational Research Institute

Orlando, Florida, United States

Countries

United States

Other Identifiers

1605203

Identifier Type: -

Identifier Source: org_study_id