Official Title
Determination of Hemoglobin A1c, Lipid Profiles, Homocysteine, Oxidative Stress Parameters and Physical Activity Levels in Patients With Type II Diabetes and/or COVID-19
Brief Summary

It is known that COVID-19 has a more negative clinical course and causes higher degrees of morbidity and mortality in case of COVID-19 in diabetic patients. However, the contribution of COVID-19 to hyperglycemia and its effect on glycemic parameters are uncertain. However, it is important to investigate homocysteine and lipid profile levels, respectively, and free radical levels known to be effective in the development of cardiovascular disease and diabetes due to oxidative stress, which can provide information about the identification and diagnosis of cardiovascular complications in the COVID-19 pandemic. In addition, as the decrease in physical activity levels of individuals in the COVID-19 pandemic may cause possible secondary complications such as an increase in the risk of cardiovascular disease, determining the physical activity levels of individuals and encouraging them to physical activity is another important parameter to minimize the negative effects of the process. Patients who applied to Izmir Bakircay University Cigli Training and Research Hospital (Cigli Regional Education Hospital) and hospitalized in the COVID-19 service and healthy controls are planning to include in this study. Patients diagnosed with COVID-19 will be included in Group I (n: 20), patients diagnosed with both Type II Diabetes Mellitus and COVID-19 will be included in Group II (n: 20) and healthy controls will be included in Group III (n:20). Hemoglobin A1c levels, lipid profiles, homocysteine, free radical levels and physical activity levels will be compared between groups. In addition, the change in the relevant variables before and after COVID-19 treatment will be determined by in-group comparisons in Group I and Group II. This study, which has a prospective and randomized controlled research plan, is planned to be carried out between January and February 2021. Research data will be obtained from blood samples taken from participants. In addition, data on physical activity levels will be collected through a questionnaire. After analyzing the data obtained from the research with appropriate statistical methods, the data will be evaluated.

Detailed Description

The coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) results in significantly higher morbidity and mortality in
patients with concomitant diseases such as diabetes mellitus and hypertension.

Glycemic management is of much more interest for both diabetes and COVID-19 patients, as
diabetes has been reported to be associated with the poor prognosis of COVID-19. There is
evidence that better glycemic control in COVID-19 patients is closely related to improved
clinical outcomes. However, whether COVID-19 contributes to hyperglycemia is confusing. It
remains unclear regarding the impact of COVID-19 infection on glycemic parameters, including
blood glucose and hemoglobin A1c (HbA1c).

Lipid profile assessment is an important tool that helps diagnose cardiovascular diseases.
Therefore, the stability of the samples is crucial for the analysis of total cholesterol
(TC), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol
(HDL-C) and triglycerides (TG).Stability is the ability of analyte concentrations to be
minimally affected within an acceptable range over a period of time.

High plasma homocysteine levels significantly increase the incidence of vascular damage in
both small and large vessels. Concentrations above the 90th percentile are associated with an
increased risk of degenerative and atherosclerotic processes in the coronary, cerebral and
peripheral circulatory systems. Although homocysteine is an effective cardiovascular risk
biomarker and is critical for cardiovascular complications in hospitalized COVID-19 patients,
studies on this parameter have not focused much on laboratory markers useful for clinical
evaluation of COVID-19.

Free radicals are continuously formed at the active site of enzymes as intermediates in
enzymatic reactions occurring during cell metabolism. Reactive oxygen species and reactive
nitrogen, known as intermediates, sometimes leach from the active site of enzymes and
accidentally interact with molecular oxygen and form free oxygen radicals.Lipids, proteins,
enzymes, carbohydrates, and DNA can be damaged due to oxidative stress, random breaks and
bonds in DNA chains may occur as a result of damage to membranes, damage to enzymes and
structural proteins may result in cell death, and these phenomena may result in cancer,
neurodegenerative and cardiovascular diseases, diabetes and It constitutes the molecular
basis in the development of autoimmune disorders.

The general recommendation for thinking that an adult is physically active is to achieve at
least 150 minutes of moderate or 75 minutes of vigorous vigorous activity per week, or an
equivalent combination of both, and involving sedentary behavior, energy expenditure ≤ 1.5
metabolic equivalent (MET), while lying down, leaning, It is defined as any waking behavior
practiced while sitting or standing. As the disease spreads all over the world, healthy
people are asked to stay at home for a long time. As a result, COVID-19 has radically changed
the determinants of both behaviors (individual, interpersonal, environmental, regional or
national policies and global). Accordingly, it can be said that regular and joint activities
decrease due to isolation and limitations, especially in the first weeks when the population
has limited chances to find alternatives to keep active even at home, and reducing sedentary
behavior during closure poses a significant challenge. Because of this situation, physical
activity in the home environment is strongly encouraged by public health advocates to prevent
the potential harmful effects of protective lifestyle regulations due to COVID-19 and to
prevent the restrictions from causing physical inactivity.

The main aim of this study is to compare hemoglobin A1c levels, lipid profiles, homocysteine,
oxidative stress parameters and physical activity levels in patients with COVID-19 and
patients with both COVID-19 and Type II diabetes via healthy adults. The second aim is to
compare the initial data obtained following the hospitalization of COVID-19 patients and
patients with both COVID-19 and Type II diabetes, with the latest data obtained after
treatment and before discharge.

Unknown status
COVID19
Diabetes Mellitus, Type 2

Drug: COVID-19 group (Group I)

Routine COVID-19 treatment

Drug: Type II Diabetes Mellitus and COVID-19 group (Group II)

Routine Type II Diabetes Mellitus and COVID-19 treatments

Eligibility Criteria

Inclusion Criteria:

- To voluntarily participate in the study

- To be diagnosed with both Type II diabetes and COVID-19 for Group I

- To be diagnosed with COVID-19 for Group II

- Not having any diagnosed chronic diseases for Group III

Exclusion Criteria:

- Patients who do not need hospitalization

- Patients with a diagnosis of Type I Diabetes Mellitus

- Patients diagnosed with renal failure and/or heart failure

- Being pregnant

- Body mass index over 40kg/m2

Eligibility Gender
All
Eligibility Age
Minimum: 35 Years ~ Maximum: 65 Years
Countries
Turkey
Locations

Kadirhan Ozdemir
İzmir, Turkey

Investigator: Kadirhan Ozdemir
Contact: 05069439059
kadirhanozdemir@gmail.com

Contacts

Kadirhan Ozdemir
+905069439059
kadirhanozdemir@gmail.com

Izmir Bakircay University
NCT Number
Keywords
Hemoglobin A1c
Lipid profiles
Homocystein
Oxidative stress parameters
physical activity level
Covid19 (SARS-CoV-2)
Type II Diabetes Mellitus
MeSH Terms
COVID-19
Diabetes Mellitus
Diabetes Mellitus, Type 2