NCT04695158

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

January 6, 2021

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

February 11, 2021

Status Verified

February 1, 2021

Enrollment Period

26 days

First QC Date

January 2, 2021

Last Update Submit

February 9, 2021

Conditions

Covid19Diabetes Mellitus, Type 2

Keywords

Hemoglobin A1cLipid profilesHomocysteinOxidative stress parametersPhysical activity levelCovid19 (SARS-CoV-2)Type II Diabetes Mellitus

Outcome Measures

Primary Outcomes (6)

  • Change of the levels of Hemoglobin A1c and Lipid Profiles at baseline and discharge for Group I and Group II

    Hemoglobin A1c and lipid profiles will be determined by venous blood samples taken from the participants. Blood plasma Hemoglobin A1c levels will be analyzed using immunoturbidimetric method and Lipid Profiles including Total cholesterol, high density lipoprotein (HDL) cholesterol and Triglyceride levels will be analyzed by using colorimetric methods in Medical Biochemistry Laboratory. Very low-density lipoprotein (VLDL) cholesterol and low density lipoprotein (LDL) cholesterol will be calculated by the Friedewald formula. All these parameters will be studied on the Cobas Integra 800 biochemical analyzer (Roche Diagnostics, Gesellschaft mit beschränkter Haftung (GmbH), Mannheim, Germany).

    At baseline and immediately before the discharge

  • The levels of Hemoglobin A1c and Lipid Profiles for Group III

    Hemoglobin A1c and lipid profiles will be determined by venous blood samples taken from the participants. Blood plasma Hemoglobin A1c levels will be analyzed using immunoturbidimetric method and Lipid Profiles including Total cholesterol, HDL-C and Triglyceride levels will be analyzed by using colorimetric methods in Medical Biochemistry Laboratory. VLDL-C and LDL-C will be calculated by the Friedewald formula. All these parameters will be studied on the Cobas Integra 800 biochemical analyzer (Roche Diagnostics, GmbH, Mannheim, Germany).

    At baseline

  • Change of the levels of Homocystein and Oxidative Stress Parameters at baseline and discharge for Group I and Group II

    Homocystein levels will be studied by using Enzyme Chemiluminescence Immunoassay (ECLIA), and Oxidative Stress Parameters including Superoxide Dismutase (SOD), Malondialdehyde (MDA), Total Antioxidant Level (TAL) / Total Oxidant Level (TOL) will be studied by photometric method in Medical Biochemistry Laboratory.

    At baseline and immediately before the discharge

  • The levels of Homocystein and Oxidative Stress Parameters for Group III

    Homocystein levels will be studied by using Enzyme Chemiluminescence Immunoassay (ECLIA), and Oxidative Stress Parameters including Superoxide Dismutase (SOD), Malondialdehyde (MDA), Total Antioxidant Level (TAL) / Total Oxidant Level (TOL) will be studied by photometric method in Medical Biochemistry Laboratory.

    At baseline

  • Change of Physical Activity Level at baseline and discharge for Group I and Group II

    International Physical Activity Questionnaire-Short Form (IPAQ-SF) will be used to determine the level of physical activity for last 7 days. This questionnaire consists of 7 questions and provides information about sitting, walking, moderate activities and time spent on vigorous activities. The calculation of the total score includes the total duration and frequency of walking, moderate activity, and vigorous activity. The sitting score is calculated separately. In the evaluation of all activities, the criterion is that each activity should be done at least 10 minutes. The walking time will be multiplied by 3.3 MET (The metabolic equivalent of task) in the calculation of the walking score. In the calculation, 4 METs for moderate activity and 8 METs for vigorous activity will be taken. Physical activity levels will categorize as inactivity (\<600 MET-min/week), low physical activity (600-3000 MET-min/week) and adequate physical activity (\>3000 MET-min/week) minutes/week).

    At baseline and immediately after the recovery

  • Physical Activity Level for Group III

    International Physical Activity Questionnaire-Short Form (IPAQ-SF) will be used to determine the level of physical activity for last 7 days. This questionnaire consists of 7 questions and provides information about sitting, walking, moderate activities and time spent on vigorous activities. The calculation of the total score includes the total duration and frequency of walking, moderate activity, and vigorous activity. The sitting score is calculated separately. In the evaluation of all activities, the criterion is that each activity should be done at least 10 minutes. The walking time will be multiplied by 3.3 MET (The metabolic equivalent of task) in the calculation of the walking score. In the calculation, 4 METs for moderate activity and 8 METs for vigorous activity will be taken. Physical activity levels will categorize as inactivity (\<600 MET-min/week), low physical activity (600-3000 MET-min/week) and adequate physical activity (\>3000 MET-min/week) minutes/week).

    At baseline and immediately after the recovery

Secondary Outcomes (2)

  • Change of the levels of Routine Blood Samples at baseline and discharge for Group I and Group II

    At baseline and immediately before the discharge

  • The levels of Routine Blood Samples for Group III

    At baseline

Study Arms (3)

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.

Drug: COVID-19 group (Group I)

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.

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

Control group (Group III)

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

Interventions

COVID-19 group (Group I)DRUG

Routine COVID-19 treatment

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

Routine Type II Diabetes Mellitus and COVID-19 treatments

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

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants in Group I and Group II will be included the study from Izmir Bakircay University Cigli Training and Research Hospital (Cigli Regional Training Hospital). Participants in Group III will be included the study from community sample.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kadirhan Ozdemir

Izmir, 06580, Turkey (Türkiye)

RECRUITING

Related Links

MeSH Terms

Conditions

COVID-19Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Kadirhan Ozdemir

CONTACT

+905069439059kadirhanozdemir@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

January 2, 2021

First Posted

January 5, 2021

Study Start

January 6, 2021

Primary Completion

February 1, 2021

Study Completion

March 1, 2021

Last Updated

February 11, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)