HypertensionNCT05890989
Relationship of Epicardial Adiposity With Sedentary Time, Physical Activity and Performance in Hypertensives
An observational study of Hypertension, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
Trial summary
Epicardial adipose tissue is associated with the development of cardiovascular disease and its increase is positively correlated with blood pressure elevation in hypertensive individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- EPICARDIAL ADIPOSIS TISSUE AND PHYSICAL PERFORMANCE MEASUREMENT
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Dec 2021to 28 Feb 2022
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteers who had been diagnosed with hypertension for at least 6 months
Who may be able to join
- Volunteering to participate in the study
- Being diagnosed with hypertension for at least 6 months
- Speaking Turkish
- to be able to read and write,
- To be between 18-65 years old
Who cannot join
- Severe valvular disease
- be heart failure
- being cardiomyopathy
- having chronic kidney disease
- being thyroid diseases
- active infectious or inflammatory diseases
- serious psychiatric illnesses such as panic disorder or major depression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Epicardial Adipose Tissue Thickness and Sedentary Time, Physical Activity Level, and Physical Performance in Patients With Hypertension
Epicardial adipose tissue is associated with the development of cardiovascular disease and its increase is positively correlated with blood pressure elevation in hypertensive individuals. In the literature, being physically active has been shown to be effective in the treatment of hypertension and reduction of epicardial adipose tissue thickness. The aim of this study was to evaluate the relationship between epicardial adipose tissue thickness and sedentary time, physical activity level and physical performance in patients with hypertension. The study included 40 patients with hypertension. The physical and demographic characteristics of the participants were collected using a sociodemographic form. Waist/hip circumference was measured with tape measure and epicardial adipose tissue thickness with echocardiography device. Physical activity levels and sedentary time were recorded via IPAQ-7. Physical performance was determined using the 30-s sit-and-stand test. There is no previous study in the literature evaluating the relationship between epicardial adipose tissue thickness and sedentary time and physical activity levels in hypertensive patients. With this study, we aim to contribute to the literature by filling this deficiency.
- Conditions
- Hypertension
- Being tested
- EPICARDIAL ADIPOSIS TISSUE AND PHYSICAL PERFORMANCE MEASUREMENT
- Keywords
- Epicardial adipose tissue, Hypertension, Physical activity, Sedentary time, Physical performance
- Medical subject headings
- Hypertension, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPICARDIAL ADIPOSIS TISSUE AND PHYSICAL PERFORMANCE MEASUREMENTDiagnostic test
EPICARDIAL ADIPOSIS TISSUE AND PHYSICAL PERFORMANCE MEASUREMENT OF THE PARTICIPANTS WAS MADE.
| Study group | Role | What they receive |
|---|---|---|
| INCREASED EPICARDIAL ADIPOSIS TISSUE | Not described Receives: Diagnostic Test: EPICARDIAL ADIPOSIS TISSUE AND PHYSICAL PERFORMANCE MEASUREMENT |
What is being measured
The primary outcome is the main question the study is designed to answer.
EPICARDIAL ADIPOSIS TISSUE MEASUREMENT
All patients underwent transthoracic echocardiography conducted by a single cardiologist using a Philips HD11XE (Philips Medical Systems) device in the left lateral decubitus position by the standard technique. Epicardial fat thickness was measured in the parasternal long axis imaging window, using the aortic annulus as an anatomical indicator for vertical measurement, and the widest part of the region from the right ventricular free wall to the pericardium at the end of the systole.
Measured: measured at admission
Secondary outcomes (1)
PHYSICAL PERFORMANCE
The physical performance of the participants was evaluated with the 30-second sit-and-stand test. While seated in a chair with a seat height of 43.2 cm and a supported back, the patient was asked to stand up and sit down as quickly as possible while crossing his/her hands over his/her chest. The 30-second duration of the test was monitored with a stopwatch and the number of times the participant stood up and sat down was noted. Two trials were performed before the test.
Measured: measured at admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start6 Dec 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Collaborators
- Karaman Training and Research Hospital
- Responsible party
- Principal investigator, Emine Tunç Süygün, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890989
- Sponsor's protocol ID
- KMU-TUNCSUYGUN-001
- Status last verified
- May 2023
- First submitted
- 16 May 2023
- Last updated
- 6 Jun 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 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Epicardial Adipose Tissue Thickness and Sedentary Time, Physical Activity Level, and Physical Performance in Patients With Hypertension
- ClinicalTrials.gov ID
- NCT05890989
- Acronym / sponsor ID
- KMU-TUNCSUYGUN-001
- Conditions
- Hypertension
- Keywords
- Epicardial adipose tissue, Hypertension, Physical activity, Sedentary time, Physical performance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Collaborators
- Karaman Training and Research Hospital
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 6 Jun 2023 (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.
Epicardial adipose tissue is associated with the development of cardiovascular disease and its increase is positively correlated with blood pressure elevation in hypertensive individuals. In the literature, being physically active has been shown to be effective in the treatment of hypertension and reduction of epicardial adipose tissue thickness. The aim of this study was to evaluate the relationship between epicardial adipose tissue thickness and sedentary time, physical activity level and physical performance in patients with hypertension. The study included 40 patients with hypertension. The physical and demographic characteristics of the participants were collected using a sociodemographic form. Waist/hip circumference was measured with tape measure and epicardial adipose tissue thickness with echocardiography device. Physical activity levels and sedentary time were recorded via IPAQ-7. Physical performance was determined using the 30-s sit-and-stand test. There is no previous study in the literature evaluating the relationship between epicardial adipose tissue thickness and sedentary time and physical activity levels in hypertensive patients. With this study, we aim to contribute to the literature by filling this deficiency.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INCREASED EPICARDIAL ADIPOSIS TISSUE | – | Diagnostic Test: EPICARDIAL ADIPOSIS TISSUE AND PHYSICAL PERFORMANCE MEASUREMENT |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers who had been diagnosed with hypertension for at least 6 months
Key inclusion criteria (5 listed)
- Volunteering to participate in the study
- Being diagnosed with hypertension for at least 6 months
- Speaking Turkish
- to be able to read and write,
- To be between 18-65 years old
Key exclusion criteria (7 listed)
- Severe valvular disease
- be heart failure
- being cardiomyopathy
- having chronic kidney disease
- being thyroid diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPICARDIAL ADIPOSIS TISSUE AND PHYSICAL PERFORMANCE MEASUREMENTEPICARDIAL ADIPOSIS TISSUE AND PHYSICAL PERFORMANCE MEASUREMENT OF THE PARTICIPANTS WAS MADE. | Diagnostic test | INCREASED EPICARDIAL ADIPOSIS TISSUE |
Primary outcome
EPICARDIAL ADIPOSIS TISSUE MEASUREMENT
Time frame: measured at admission
All patients underwent transthoracic echocardiography conducted by a single cardiologist using a Philips HD11XE (Philips Medical Systems) device in the left lateral decubitus position by the standard technique. Epicardial fat thickness was measured in the parasternal long axis imaging window, using the aortic annulus as an anatomical indicator for vertical measurement, and the widest part of the region from the right ventricular free wall to the pericardium at the end of the systole.
1 secondary outcome
PHYSICAL PERFORMANCE
Time frame: measured at admission
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 6 Jun 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 Hypertension, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
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 5 inclusion and 7 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 6 Jun 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 Turkey (Türkiye). 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?
EPICARDIAL ADIPOSIS TISSUE MEASUREMENT (time frame: measured at admission). 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 6 Jun 2023.