- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04373863
Assessment of Lifestyle, Blood Pressure, Cholesterol and Glycated Hemoglobin in a Specific Population (LB1901)
October 10, 2023 updated by: Libbs Farmacêutica LTDA
Let's Get to Know Your Health Better? Assessment of Lifestyle, Blood Pressure and Cholesterol in the Population of Employees Libbs Farmacêutica LTDA.
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.
Study Overview
Status
Completed
Detailed 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 Farmacêutica 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.
Study Type
Observational
Enrollment (Actual)
2472
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Augusto T Figueiredo
- Phone Number: 1246 55 11 3879 2500
- Email: augusto.figueiredo@libbs.com.br
Study Contact Backup
- Name: Lara F Yokoya, Dr
- Phone Number: 1987 55 11 3879 2500
- Email: lara.faco@libbs.com.br
Study Locations
-
-
-
São Paulo, Brazil, 01140050
- Augusto Theodoro de Figueiredo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
This research project will be conducted during various internal and external institutional events, and in specific actions carried out at Libbs units located in Barra Funda (administrative unit) and in the city of Embu das Artes (production unit).
Description
Inclusion Criteria:
- Being an employee Libbs Farmacêutica Ltda;
Exclusion Criteria:
- not applicable
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Descriptive questionnaire
Time Frame: until December 2020
|
Descriptive information about lifestyle and family history and through exams, blood pressure and serum cholesterol values in the population of Libbs Farmacêutica Ltda employees.
|
until December 2020
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of hypercholesterolemia and arterial hypertension
Time Frame: until December 2020
|
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
|
Glycated hemoglobin (HbA1c) values
Time Frame: until December 2020
|
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
|
Data correlation
Time Frame: until December 2020
|
|
until December 2020
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 29, 2020
Primary Completion (Actual)
August 30, 2021
Study Completion (Actual)
January 19, 2023
Study Registration Dates
First Submitted
April 30, 2020
First Submitted That Met QC Criteria
April 30, 2020
First Posted (Actual)
May 5, 2020
Study Record Updates
Last Update Posted (Actual)
October 11, 2023
Last Update Submitted That Met QC Criteria
October 10, 2023
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LB1901
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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