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REsearching Covid-19 Outcomes in Diabetes (RECODE) (RECODE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04805970
Recruitment Status : Recruiting
First Posted : March 18, 2021
Last Update Posted : May 11, 2021
Sponsor:
Information provided by (Responsible Party):
AdventHealth Translational Research Institute

Study Description
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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.

Condition or disease
Covid19 Diabetes

Study Design
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Study Type : Observational
Estimated Enrollment : 66 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: REsearching Covid-19 Outcomes in Diabetes (RECODE)
Actual Study Start Date : March 24, 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Patients with and without diabetes who were previously diagnosed with COVID-19


Outcome Measures
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Primary Outcome Measures :
  1. Measure and characterize organ volume change in patients with and without diabetes through use of summary statistics. [ Time Frame: 1 year ]
    Patients recovering from the COVID-19 disease


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04805970


Contacts
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Contact: Recruitment Department 407-303-7100 Fh.tri.recruitment@adventhealth.com

Locations
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United States, Florida
AdventHealth Translational Research Institute Recruiting
Orlando, Florida, United States, 32804
Contact: Recruitment Department    407-303-7100    Fh.tri.recruitment@adventhealth.com   
Sponsors and Collaborators
AdventHealth Translational Research Institute
Investigators
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Principal Investigator: Richard Pratley, MD AdventHealth Orlando
More Information
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Responsible Party: AdventHealth Translational Research Institute
ClinicalTrials.gov Identifier: NCT04805970    
Other Study ID Numbers: 1605203
First Posted: March 18, 2021    Key Record Dates
Last Update Posted: May 11, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Respiratory Tract Infections
Infections
Pneumonia, Viral
 Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases