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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04373863
Other study ID # LB1901
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 29, 2020
Est. completion date January 19, 2023

Study information

Verified date July 2022
Source Libbs Farmacêutica LTDA
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The project Shall we get to know your health better? Lifestyle assessment, blood pressure and cholesterol in the population of Libbs Farmacêutica employeesLTDA.; consists of a study that will bring knowledge and enable quantificationof risk factors related to cardiovascular diseases in this population above mentioned.


Description:

The social relevance of this study is related to the knowledge and quantification of eating habits and lifestyles related to cardiovascular diseases in the population of employees, also referred to in this document as "employees", from Libbs FarmacĂȘutica Ltda. Based on an observation and statistical analysis of the data obtained in this study, internal policies will be promoted that aim to improve eating habits, physical activity and decrease smoking.


Recruitment information / eligibility

Status Completed
Enrollment 2472
Est. completion date January 19, 2023
Est. primary completion date August 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - Being an employee Libbs FarmacĂȘutica Ltda; Exclusion Criteria: - not applicable

Study Design


Locations

Country Name City State
Brazil Augusto Theodoro de Figueiredo São Paulo

Sponsors (1)

Lead Sponsor Collaborator
Libbs Farmacêutica LTDA

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Descriptive questionnaire Descriptive information about lifestyle and family history and through exams, blood pressure and serum cholesterol values in the population of Libbs FarmacĂȘutica Ltda employees. until December 2020
Secondary Prevalence of hypercholesterolemia and arterial hypertension Quantify the prevalence of hypercholesterolemia (serum total cholesterol above 200mg / dL - worst case) and hypertension (systolic blood pressure above 140mmHg or diastolic blood pressure above 90mmHg - worst case) until December 2020
Secondary Glycated hemoglobin (HbA1c) values Track the glycated hemoglobin (HbA1c) values of the research participants, in order to know the average blood glucose levels in the last 3 months before the day of the exam and quantify the prevalence of participants who have HbA1c above the value considered normal in literature, which is up to 5.6% (best scenario) until December 2020
Secondary Data correlation Correlate eating habits with socioeconomic characteristics;
Correlate the values of serum cholesterol, blood pressure and glycated hemoglobin with eating habits, level of physical activity practiced and prevalence of smoking
until December 2020
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