Cholesterol; LipidosisLB1901NCT04373863
Assessment of Lifestyle, Blood Pressure, Cholesterol and Glycated Hemoglobin in a Specific Population
An observational study of Cholesterol; Lipidosis and Arterial Hypertension, run by Libbs Farmacêutica LTDA at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cholesterol; Lipidosis, Arterial Hypertension, Blood Glucose, High
- How many people
- 2,472 participants
- Where
- 1 siteBrazil
- Study dates
- 29 Jun 2020to 19 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- Being an employee Libbs Farmacêutica Ltda;
Who cannot join
- not applicable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Keywords
- glycated hemoglobin, Cholesterol, Arterial Hypertension, smoking
- Medical subject headings
- Lipidoses, Hypertension, Smoking
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive questionnaire
Descriptive information about lifestyle and family history and through exams, blood pressure and serum cholesterol values in the population of Libbs Farmacêutica Ltda employees.
Measured: until December 2020
Secondary outcomes (3)
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)
Measured: until December 2020
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)
Measured: until December 2020
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
Measured: until December 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start29 Jun 2020
- Primary completion30 Aug 2021
- Study completion19 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholesterol; LipidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,472 participants (actual)
Sponsor and investigators
- Lead sponsor
- Libbs Farmacêutica LTDA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373863
- Sponsor's protocol ID
- LB1901
- Acronym
- LB1901
- Status last verified
- Jul 2022
- First submitted
- 30 Apr 2020
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Let's Get to Know Your Health Better? Assessment of Lifestyle, Blood Pressure and Cholesterol in the Population of Employees Libbs Farmacêutica LTDA.
- ClinicalTrials.gov ID
- NCT04373863
- Acronym / sponsor ID
- LB1901 / LB1901
- Keywords
- glycated hemoglobin, Cholesterol, Arterial Hypertension, smoking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,472 participants (actual)
- Lead sponsor
- Libbs Farmacêutica LTDAIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 19 Jan 2023 (actual)
- First posted
- 5 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- Being an employee Libbs Farmacêutica Ltda;
Key exclusion criteria (1 listed)
- not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Prevalence of hypercholesterolemia and arterial hypertension
Time frame: until December 2020
Glycated hemoglobin (HbA1c) values
Time frame: until December 2020
Data correlation
Time frame: until December 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholesterol; Lipidosis and Arterial Hypertension, run by Libbs Farmacêutica LTDA at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive questionnaire (time frame: until December 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023.