Clinical trial NCT04805970: REsearching Covid-19 Outcomes in Diabetes (RECODE)
Official title: REsearching Covid-19 Outcomes in Diabetes (RECODE)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Covid19
Diabetes
Lead sponsor: AdventHealth Translational Research Institute
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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.


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.

Primary outcomes:
measure: Measure and characterize organ volume change in patients with and without diabetes through use of summary statistics.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: AdventHealth Translational Research Institute
state: Florida
Study officials:
affiliation: AdventHealth Orlando
name: Richard Pratley, MD
role: PRINCIPAL_INVESTIGATOR
References: