COVID-19, Aging, and Cardiometabolic Risk Factors Study

NCT04802044 | Unknown

• 1 other identifier: CARAMEL
• Study Type: observational
• Target: 440
• Locations: 1 country
• Sites: 2

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.

Conditions

Covid19; Obesity; Diabetes Mellitus; Aging; Cardiometabolic Syndrome; Immune System Disorder

Keywords

COVID-19; adiposity; diabetes; insulin resistance; aging; inflammation; immune system

Outcome Measures

Primary Outcomes (4)

• Correlation of Body Mass Index with Clinical Disease Severity

  To compare the body mass index, which calculated from body height (in meters) and body weight (in kilograms), in groups of COVID-19 patients with various disease severity based on WHO criteria

  Baseline

• Correlation of Visceral Fat with Clinical Disease Severity

  To compare the visceral fat that measures using a bio-impedance analyzer, in groups of COVID-19 patients with various disease severity based on WHO criteria

  Baseline

• Correlation of Blood Glucose Levels with Clinical Disease Severity

  To compare the random blood glucose levels during admission in groups of COVID-19 patients with various disease severity based on WHO criteria

  Baseline

• Correlation of HbA1c with Clinical Disease Severity

  To compare the HbA1c levels during admission in groups of COVID-19 patients with various disease severity based on WHO criteria

  Baseline

Secondary Outcomes (11)

• Changes of Insulin Resistance Levels in COVID-19 Patients Overtime

  Baseline, 6, and 12 month

• Changes of Leptin/Adiponectin Ratio in COVID-19 Patients Overtime

  Baseline, 6, and 12 month

• Systemic Immune Profiles in Diabetic COVID-19 Patients

  Baseline

• Nasal Mucosal Immune Profiles in Diabetic COVID-19 Patients

  Baseline

• Aging Parameter (ACE-2 gene expression) in COVID-19 Patients

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COVID-19 patients in hospital and community setting

You may qualify if:

• Patients newly diagnosed with COVID-19 at hospital setting or community screening, confirmed with biological proof (RT-PCR)

You may not qualify if:

• Subjects opposed to the use of their data
• Minors, adults under guardianship, protected persons
• History of malignancy
• History of autoimmune disease
• Pregnancy

Sponsors & Collaborators

• Indonesia University: lead
• Leiden University Medical Center: collaborator

Study Sites (2)

Dr. Cipto Mangunkusumo National General Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Metabolic Disorder, Cardiovascular, and Aging Research Cluster IMERI-FKUI, Research Tower, 5th Floor

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Related Publications (32)

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Biospecimen

Retention: SAMPLES WITH DNA

Serum Urine PBMC Nasal scrape Nasal swab

MeSH Terms

Conditions

COVID-19; Obesity; Diabetes Mellitus; Metabolic Syndrome; Immune System Diseases; Insulin Resistance; Inflammation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Pathologic Processes

Study Officials

• Dicky L Tahapary

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 30, 2021
• First Posted: March 17, 2021
• Study Start: December 8, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: April 18, 2022

Record last verified: 2022-04

Locations

ID (2)