Impact of Adipose Tissue in COVID-19 (COVIFAT)

November 19, 2020 updated by: Assistance Publique - Hôpitaux de Paris

Impact of Adipose Tissue in COVID-19 : From Pathophysiology to Therapeutic Perspectives

Overweight or obese patients are particularly exposed to severe forms of COVID-19. Few data suggest that adipose tissue infected with SARS-CoV-2 could be involved in the onset of the cytokine storm seen in severe forms of COVID-19. The aim of this study is to determine the pathogenesis of SARS-CoV-2-infection of adipose tissue. In particular the investigators will study how this virus enters the adipocyte and how it modulates metabolism and inflammation in the adipose tissue. From these data, the investigators hope to determine at the adipose tissue level, original therapeutic targets to modulate the effects of SARS-CoV-2 at the systemic level.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • Hôpital de la Pitié Salpêtrière

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Obese and thin patients operated on for abdominal vascular surgery.

Description

Inclusion Criteria:

  • Age greater than or equal to 18 years
  • All patients who are obese or overweight (> 25 kg/m2) or non-obese (< or = 25 kg/m2) operated for abdominal vascular surgery
  • Beneficiary or entitled to a social security scheme (except AME)

Exclusion Criteria:

  • Pregnant or breastfeeding woman
  • Patient refusal
  • Patient deprived of liberty or subject to a legal protection measure (guardianship, curatorship)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Obese or overweight patients
Other: Adipose tissue
Adipose tissue sampling
Patients without overweight
Other: Adipose tissue
Adipose tissue sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the expression of ACE2 and TMPRSS2 in the subcutaneous and visceral adipose tissue of obese patients. Determination of cells expressing ACE2 and TMPRSS2 in whole human adipose tissue.
Time Frame: 12 months
Analysis of the expression of mRNA and ACE2 and TMPRSS2 proteins in the subcutaneous and visceral adipose tissue of normal weight and obese patients
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demonstration of entry and replication of SARS-CoV-2 in human adipose tissue
Time Frame: 12 months
Infection of human adipocytes in lean and obese subjects by SARS-CoV-2
12 months
Consequences of infection with SARS-CoV-2 on the metabolism and inflammatory state of adipose tissue.
Time Frame: 12 months

Assessment of the expression and secretion of inflammatory cytokines (TNF-α, IL-1 , IL-4 , IL-6 , IL-7 , IL-10 , IL-12 , IL-13 , IL-18 ¸ IL-23, INF-α, INF-β) after infection with SARS-CoV-2 of adipose tissue / adipocytes of thin and obese subjects.

Evaluation of SARS-CoV-2 infection on the lipolysis of adipose tissue / adipocytes in thin and obese subjects.
12 months
Consequences of infection with SARS-CoV-2 on the metabolism and inflammatory state of adipose tissue.
Time Frame: 12 months
Evaluation of SARS-CoV-2 infection on the lipolysis of adipose tissue / adipocytes in thin and obese subjects.
12 months
Effect of SARS-CoV-2 infection of adipose tissue / adipocytes from thin and obese subjects on endoplasmic reticulum (ER) homeostasis.
Time Frame: 12 months
Study whether infection with SARS-CoV-2 activates the RE stress pathways in adipose tissue
12 months
Target endoplasmic reticulum stress to reduce spread of SARS-CoV-2 from adipose tissue
Time Frame: 12 months
Use of RE stress inhibitors on adipocytes infected with SARS-CoV-2 and assess their effect on the maturation of the virus in infected cells.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Olivier BOURRON, Dr, Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 23, 2020

Primary Completion (Anticipated)

November 22, 2021

Study Completion (Anticipated)

November 23, 2021

Study Registration Dates

First Submitted

October 28, 2020

First Submitted That Met QC Criteria

November 19, 2020

First Posted (Actual)

November 20, 2020

Study Record Updates

Last Update Posted (Actual)

November 20, 2020

Last Update Submitted That Met QC Criteria

November 19, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP200983
  • 2020-A02403-36 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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