Clinical trial NCT04802044: COVID-19, Aging, and Cardiometabolic Risk Factors Study
Official title: COVID-19, Aging, and Cardiometabolic Risk Factors (CARAMEL) Study: Integrating Aging, Cardiovascular, Metabolic, and Immunological Studies to Unravel COVID-19 Pathophysiology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Obesity
Diabetes Mellitus
Aging
Cardiometabolic Syndrome
Immune System Disorder
Keywords: COVID-19
adiposity
diabetes
insulin resistance
aging
inflammation
immune system
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: Leiden University Medical Center
First posted: 2021-03-17
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID-19 patients in hospital and community setting

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation of Body Mass Index with Clinical Disease Severity
timeFrame: Baseline
measure: Correlation of Visceral Fat with Clinical Disease Severity
timeFrame: Baseline
measure: Correlation of Blood Glucose Levels with Clinical Disease Severity
timeFrame: Baseline
measure: Correlation of HbA1c with Clinical Disease Severity
timeFrame: Baseline
Secondary outcomes:
measure: Changes of Insulin Resistance Levels in COVID-19 Patients Overtime
timeFrame: Baseline, 6, and 12 month
measure: Changes of Leptin/Adiponectin Ratio in COVID-19 Patients Overtime
timeFrame: Baseline, 6, and 12 month
measure: Systemic Immune Profiles in Diabetic COVID-19 Patients
timeFrame: Baseline
measure: Nasal Mucosal Immune Profiles in Diabetic COVID-19 Patients
timeFrame: Baseline
measure: Aging Parameter (ACE-2 gene expression) in COVID-19 Patients
timeFrame: Baseline
measure: Aging Parameter (Telomere Length) in COVID-19 Patients
timeFrame: Baseline
measure: Immune Cells Exhaustion in COVID-19 Patients
timeFrame: Baseline
measure: Changes of Pro-Inflammatory Cytokine (IL-6) in COVID-19 Patients
timeFrame: Baseline, 1, 3, and 6 months
measure: Changes of Anti-Inflammatory Cytokine (IL-10) in COVID-19 Patients
timeFrame: Baseline, 1, 3, and 6 months
measure: Antibody Kinetics in COVID-19 Patients
timeFrame: Baseline, 1, 3, and 6 months
measure: Proportion of Long COVID Syndrome
timeFrame: 3, 6, and 12 months
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Dr. Cipto Mangunkusumo National General Hospital
state: DKI Jakarta
city: Jakarta Pusat
country: Indonesia
facility: Metabolic Disorder, Cardiovascular, and Aging Research Cluster IMERI-FKUI, Research Tower, 5th Floor
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Dicky L Tahapary
role: PRINCIPAL_INVESTIGATOR
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