COVID-19, Aging, and Cardiometabolic Risk Factors Study
NCT ID: NCT04802044
Last Updated: 2022-04-18
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Total Enrollment
440 participants
Study Classification
OBSERVATIONAL
Study Start Date
2020-12-08
Study Completion Date
2023-12-31
Brief Summary
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COVID-19 pandemic has made a tremendous impact on Indonesian economic and health care system especially with the double burden of diseases facing by Indonesia as a developing country. The prevalence of non-communicable diseases such as obesity, type diabetes, and cardiovascular diseases is increasing. These diseases along with older age have been known as an established risk factors for higher mortality and severe clinical disease entity in COVID-19 infection. Although, there is still some part of patients with these co-morbidities that only present with mild symptoms when infected with SARS-CoV-2, even for some without any symptoms. Thus, it would be very interesting to evaluate how are these role of aging and cardiometabolic parameters in the clinical disease course of COVID-19 infection, and how are the relationship with the immune system.
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Detailed Description
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Indonesia is a country in transition where the burden of non-communicable diseases is taking over the infectious diseases problem, mostly due to the changes in lifestyle and increase in life expectancy.
However, the unprecedented rising numbers of COVID-19 patients in Indonesia has impacted the Indonesian healthcare system heavily. It has been reported that older age and the presence of cardiometabolic risk factors pose a poor prognostic factor of COVID-19. It is also important to note that in Indonesia, the presence of cardiometabolic risk factors is often observed at a younger age. Thus, this might also contribute to the higher mortality of COVID19 infected patients despite their relatively younger age in comparison to other countries. Nevertheless, specific data on the impact of aging and cardiometabolic risk factors on COVID-19 are fragmentary, justifying the achievement of a dedicated prospective observational study.
The CARAMEL study aims to specifically describe the phenotypic aging and cardiometabolic characteristics of patients with COVID-19 infection, in relation with the changes in the mucosal and systemic immune system. Particular attention will be devoted to obesity, central obesity, prediabetes, diabetes, hypertension, dyslipidemia, as well as anti-diabetic, antihypertensive, and anti-dyslipidemia therapies.
This study will provide answers to researchers, medical professionals, and especially patients, regarding the impact of aging and cardiometabolic risk factors for COVID-19 prognosis. This pilot study will be used for the development of new studies and for the establishment of recommendations for the care of patients with cardiometabolic risk factors and COVID-19.
However, the unprecedented rising numbers of COVID-19 patients in Indonesia has impacted the Indonesian healthcare system heavily. It has been reported that older age and the presence of cardiometabolic risk factors pose a poor prognostic factor of COVID-19. It is also important to note that in Indonesia, the presence of cardiometabolic risk factors is often observed at a younger age. Thus, this might also contribute to the higher mortality of COVID19 infected patients despite their relatively younger age in comparison to other countries. Nevertheless, specific data on the impact of aging and cardiometabolic risk factors on COVID-19 are fragmentary, justifying the achievement of a dedicated prospective observational study.
The CARAMEL study aims to specifically describe the phenotypic aging and cardiometabolic characteristics of patients with COVID-19 infection, in relation with the changes in the mucosal and systemic immune system. Particular attention will be devoted to obesity, central obesity, prediabetes, diabetes, hypertension, dyslipidemia, as well as anti-diabetic, antihypertensive, and anti-dyslipidemia therapies.
This study will provide answers to researchers, medical professionals, and especially patients, regarding the impact of aging and cardiometabolic risk factors for COVID-19 prognosis. This pilot study will be used for the development of new studies and for the establishment of recommendations for the care of patients with cardiometabolic risk factors and COVID-19.
Conditions
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Covid19
Obesity
Diabetes Mellitus
Aging
Cardiometabolic Syndrome
Immune System Disorder
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Patients newly diagnosed with COVID-19 at hospital setting or community screening, confirmed with biological proof (RT-PCR)
Exclusion Criteria
* Subjects opposed to the use of their data
* Minors, adults under guardianship, protected persons
* History of malignancy
* History of autoimmune disease
* Pregnancy
* Minors, adults under guardianship, protected persons
* History of malignancy
* History of autoimmune disease
* Pregnancy
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Leiden University Medical Center
OTHER
Sponsor Role
collaborator
Indonesia University
OTHER
Sponsor Role
lead
Responsible Party
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Dicky L. Tahapary
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Dicky L Tahapary
Role: PRINCIPAL_INVESTIGATOR
Indonesia University
Locations
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Dr. Cipto Mangunkusumo National General Hospital
Jakarta Pusat, DKI Jakarta, Indonesia
Site Status
Metabolic Disorder, Cardiovascular, and Aging Research Cluster IMERI-FKUI, Research Tower, 5th Floor
Jakarta Pusat, DKI Jakarta, Indonesia
Site Status
Countries
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Indonesia
References
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Sungnak W, Huang N, Becavin C, Berg M, Queen R, Litvinukova M, Talavera-Lopez C, Maatz H, Reichart D, Sampaziotis F, Worlock KB, Yoshida M, Barnes JL; HCA Lung Biological Network. SARS-CoV-2 entry factors are highly expressed in nasal epithelial cells together with innate immune genes. Nat Med. 2020 May;26(5):681-687. doi: 10.1038/s41591-020-0868-6. Epub 2020 Apr 23.
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Michalakis K, Ilias I. SARS-CoV-2 infection and obesity: Common inflammatory and metabolic aspects. Diabetes Metab Syndr. 2020 Jul-Aug;14(4):469-471. doi: 10.1016/j.dsx.2020.04.033. Epub 2020 Apr 29.
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Cervia C, Nilsson J, Zurbuchen Y, Valaperti A, Schreiner J, Wolfensberger A, Raeber ME, Adamo S, Weigang S, Emmenegger M, Hasler S, Bosshard PP, De Cecco E, Bachli E, Rudiger A, Stussi-Helbling M, Huber LC, Zinkernagel AS, Schaer DJ, Aguzzi A, Kochs G, Held U, Probst-Muller E, Rampini SK, Boyman O. Systemic and mucosal antibody responses specific to SARS-CoV-2 during mild versus severe COVID-19. J Allergy Clin Immunol. 2021 Feb;147(2):545-557.e9. doi: 10.1016/j.jaci.2020.10.040. Epub 2020 Nov 20.
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Reference Type
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Other Identifiers
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CARAMEL
Identifier Type: -
Identifier Source: org_study_id
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