COVID-19, Aging, and Cardiometabolic Risk Factors (CARAMEL) Study: Integrating Aging, Cardiovascular, Metabolic, and Immunological Studies to Unravel COVID-19 Pathophysiology
试验速览
- 阶段
- 不适用
- 入组人数
- 440
- 试验地点
- 2
- 主要终点
- Correlation of Visceral Fat with Clinical Disease Severity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients newly diagnosed with COVID-19 at hospital setting or community screening, confirmed with biological proof (RT-PCR)
排除标准
- •Subjects opposed to the use of their data
- •Minors, adults under guardianship, protected persons
- •History of malignancy
- •History of autoimmune disease
- •Pregnancy
结局指标
主要结局
Correlation of Visceral Fat with Clinical Disease Severity
时间窗: Baseline
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
Correlation of Blood Glucose Levels with Clinical Disease Severity
时间窗: Baseline
To compare the random blood glucose levels during admission in groups of COVID-19 patients with various disease severity based on WHO criteria
Correlation of Body Mass Index with Clinical Disease Severity
时间窗: Baseline
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
Correlation of HbA1c with Clinical Disease Severity
时间窗: Baseline
To compare the HbA1c levels during admission in groups of COVID-19 patients with various disease severity based on WHO criteria
次要结局
- Aging Parameter (Telomere Length) in COVID-19 Patients(Baseline)
- Immune Cells Exhaustion in COVID-19 Patients(Baseline)
- Systemic Immune Profiles in Diabetic COVID-19 Patients(Baseline)
- Changes of Leptin/Adiponectin Ratio in COVID-19 Patients Overtime(Baseline, 6, and 12 month)
- Aging Parameter (ACE-2 gene expression) in COVID-19 Patients(Baseline)
- Changes of Pro-Inflammatory Cytokine (IL-6) in COVID-19 Patients(Baseline, 1, 3, and 6 months)
- Proportion of Long COVID Syndrome(3, 6, and 12 months)
- Changes of Insulin Resistance Levels in COVID-19 Patients Overtime(Baseline, 6, and 12 month)
- Nasal Mucosal Immune Profiles in Diabetic COVID-19 Patients(Baseline)
- Changes of Anti-Inflammatory Cytokine (IL-10) in COVID-19 Patients(Baseline, 1, 3, and 6 months)
- Antibody Kinetics in COVID-19 Patients(Baseline, 1, 3, and 6 months)
研究者
Dicky L. Tahapary
Principal Investigator
Indonesia University