Blood Sample Measurements and Physical Activity Levels in Type II Diabetes and/or COVID-19

NCT ID: NCT04695158

Last Updated: 2021-02-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-06
• Study Completion Date: 2021-03-31

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.

Conditions

Covid19; Diabetes Mellitus, Type 2

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

COVID-19 group (Group I)

Patients diagnosed with COVID-19 will be in this group. No additional intervention will be applied in this group except the routine COVID-19 treatment according to the Adult Patient Treatment Guide which published by the Ministry of Health, Republic of Turkey on 9 October 2020.

COVID-19 group (Group I)

Intervention Type: DRUG

Routine COVID-19 treatment

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

Patients diagnosed with both Type II Diabetes Mellitus and COVID-19 will be in this group. No additional intervention will be applied in this group except the routine COVID-19 treatments according to the Adult Patient Treatment Guide which published by the Ministry of Health, Republic of Turkey on 9 October 2020 and routine treatment for Type II Diabetes Mellitus.

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

Intervention Type: DRUG

Routine Type II Diabetes Mellitus and COVID-19 treatments

Control group (Group III)

Healthy volunteers will be in this group. No intervention will be applied in this group.

No interventions assigned to this group

Interventions

COVID-19 group (Group I)

Routine COVID-19 treatment

Intervention Type: DRUG

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

Routine Type II Diabetes Mellitus and COVID-19 treatments

Intervention Type: DRUG

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cigli Regional Training Hospital

OTHER

Sponsor Role: collaborator

Muğla Sıtkı Koçman University

OTHER

Sponsor Role: collaborator

Izmir Bakircay University

OTHER

Sponsor Role: lead

Responsible Party

Kadirhan Ozdemir, PT, PhD.

Assist. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kadirhan Ozdemir

Izmir, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Kadirhan Ozdemir

Role: CONTACT

kadirhanozdemir@gmail.com

+905069439059

Facility Contacts

Kadirhan Ozdemir

Role: primary

kadirhanozdemir@gmail.com

05069439059

Related Links

https://covid19.saglik.gov.tr/TR-66926/eriskin-hasta-tedavisi.html

Adult Patient Treatment Guide for COVID-19 (Ministry of Health, Republic of Turkey)

Other Identifiers

2020-12-143

Identifier Type: -

Identifier Source: org_study_id