REsearching Covid-19 Outcomes in Diabetes (RECODE)

Diabetes Clinical Trial

— RECODE  

Official title:

REsearching Covid-19 Outcomes in Diabetes (RECODE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04805970
• Other study ID #: 1605203
• Status: Recruiting
• Start date: March 24, 2021
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: AdventHealth Translational Research Institute
• Contact: Recruitment Department
• Phone: 407-303-7100
• Email: Fh.tri.recruitment[@]adventhealth.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Diabetes
• Diabetes Mellitus

Locations

Country	Name	City	State
United States	AdventHealth Translational Research Institute	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AdventHealth Translational Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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