Metabolic SyndromeNCT04437979
Epicardial Fat Thickness and Inflammation in People With Metabolic Syndrome and Obesity
An observational study of Metabolic Syndrome and Obesity, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Epicardial adipose tissue (EAT) is a type of visceral adipose tissue (VAT), functioning as a metabolically active endocrine organ and suggested to play an important role in the progression of metabolic syndrome (MetS). Obesity and MetS are commonly associated with an inflammatory status. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Obesity, Inflammation
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 1 Sep 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with BMI ≥30 kg/m2, >18 years old and without manifest heart disease such as, coronary heart disease, cardiac failure, cardiac valve disease or arrythmia, renal failure, hepatic failure, infection, chronic systemic inflammatory disease, pulmonary disease and malignancy
Who may be able to join
- Having body mass index ≥30 kg/m2
Who cannot join
- Manifest heart disease ( coronary heart disease, cardiac failure, cardiac valve disease or arrythmia)
- Renal failure
- Hepatic failure
- Infection
- Chronic systemic inflammatory disease
- Pulmonary disease
- Malignancy
- Inadequate transthoracic echocardiographic images
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Research and Training Hospital
Antalya
About this study
Official title: Association of Epicardial Fat Thickness and Inflammation With the Presence of Metabolic Syndrome in People With Obesity
Epicardial adipose tissue (EAT) is a type of visceral adipose tissue (VAT), functioning as a metabolically active endocrine organ and suggested to play an important role in the progression of metabolic syndrome (MetS). Obesity and MetS are commonly associated with an inflammatory status. The aim of the study was to evaluate the association of echocardiographically measured epicardial fat thickness (EFT) and inflammation, on the basis of c-reactive protein (CRP) and neutrophil-lymphocyte ratio (NLR), with MetS and its components in people with obesity.
A total of 104 patients with body mass index (BMI)≥30 kg/m² were enrolled to the study. In all participants, EFT was measured with transthoracic echocardiography at end-systole. The patients were then classified into two groups according to whether they had MetS or not. EFT, clinical and biochemical parameters were compared between the two groups
Read the detailed description
Epicardial adipose tissue (EAT) is a kind of VAT, between the surface of the myocardium and the epicardium. It can easily be measured by standard two-dimensional (2D) echocardiography. EAT serves as an endocrin organ that secretes hormones, inflammatory cytokines and chemokines. Previous data suggests that EAT can play an active role in the development of metabolic syndrome (MetS). Previous studies have investigated the relationship between EAT/inflammatory markers and MetS/MetS components. However, there was lack of enough evidence regarding this relationship in people with obesity with or without MetS. The aim of the present study was to evaluate the association of echocardiographically measured EAT and inflammation, on the basis of c-reactive protein (CRP) and neutrophil-lymphocyte ratio (NLR), as simple and reliable indicators of inflammation, with MetS and its components in people with obesity who have similar body mass index (BMI) values. In this cross-sectional study, 104 consecutive patients with BMI ≥30 kg/m2 who presented to the 'Obesity Solution Center 'of Antalya Research and Training Hospital were included . Patients with manifest heart disease such as, coronary heart disease, cardiac failure, cardiac valve disease or arrythmia, renal failure, hepatic failure, infection, chronic systemic inflammatory disease, pulmonary disease , malignancy and inadequate transthoracic echocardiographic images were excluded. The study protocol was approved by the local ethics committee and informed consent was obtained from each subject.
Clinical information and current cardiovascular medication use were provided from each patient. Height, weight, waist circumference and hip circumference (HC) were measured when fasting and standing up with standard measuring tools. Patients were defined as having hypertension (HT) if their systolic blood pressure was >140 mmHg, their diastolic blood pressure was >90 mmHg, or they were using an antihypertensive medication. Blood samples were obtained after overnight fasting. Fasting blood glucose, urea, creatinine, total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides, CRP, fasting and postprandial insulin, C-peptid levels, vitamin D, ferritin and complete blood counts were measured using standard methods. Homeostasis model assessment of insulin resistance (HOMA-IR) was calculated using the method described by Matthews et al. NLR was defined as the log e neutrophil count/log e lymphocyte count within the peripheral blood. Patients were defined as having diabetes mellitus (DM) if they had a history of taking an oral antidiabetic or insulin medication, or if their fasting plasma glucose was ≥ 126 mg/dl. The patients were classified into two groups according to whether they had MetS or not. MetS was diagnosed according to the National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III). Epicardial fat thickness (EFT) was identified as the echo-free space in the pericardial layers on 2D echocardiography. EFT was measured on the free wall of the right ventricle at end-systole from both parasternal long axis and parasternal short axis views using the mean of three consecutive beats.
- Conditions
- Metabolic Syndrome, Obesity, Inflammation
- Keywords
- epicardial fat thickness, metabolic syndrome, obesity
- Medical subject headings
- Metabolic Syndrome, Obesity, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of the epicardial fat thickness in the presence of metabolic syndrome in people with obesity
Transthoracic echocardiography was performed to all participants with body mass index > 30 kg/m2 and epicardial fat thickness was measured. Epicardial fat thickness (EFT) was identified as the echo-free space in the pericardial layers on 2D echocardiography. EFT was measured on the free wall of the right ventricle at end-systole from both parasternal long axis and parasternal short axis views using the mean of three consecutive beats The patients were classified into two groups according to whether they had MetS or not. MetS was diagnosed according to the National Cholesterol Education Programme Adult Treatment Panel III. We evaluated the difference in epicardial fat thickness according to whether having metabolic syndrome or not, regardless of body mass index.
Measured: 1 week
Secondary outcomes (1)
Estimation of inflammation in the presence of metabolic syndrome in people with obesity
C-reactive protein and neutrophil-to-lymphocyte ratio were used to determine inflammation. The patients were classified into two groups according to whether they had MetS or not. MetS was diagnosed according to the National Cholesterol Education Programme Adult Treatment Panel III. We evaluated the difference in inflammatory mediators according to whether having metabolic syndrome or not, regardless of body mass index.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start1 Jan 2019
- Primary completion1 Jul 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Duygu Ersan Demirci, Antalya Training and Research Hospital
- Investigators
- Duygu Ersan Demirci, MD, Principal investigator, Antalya Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437979
- Sponsor's protocol ID
- 2019-397
- Status last verified
- Aug 2020
- First submitted
- 16 Jun 2020
- Last updated
- 21 Aug 2020
- 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 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Epicardial Fat Thickness and Inflammation With the Presence of Metabolic Syndrome in People With Obesity
- ClinicalTrials.gov ID
- NCT04437979
- Acronym / sponsor ID
- 2019-397
- Conditions
- Metabolic Syndrome, Obesity, Inflammation
- Keywords
- epicardial fat thickness, metabolic syndrome, obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 18 Jun 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.
Epicardial adipose tissue (EAT) is a type of visceral adipose tissue (VAT), functioning as a metabolically active endocrine organ and suggested to play an important role in the progression of metabolic syndrome (MetS). Obesity and MetS are commonly associated with an inflammatory status. The aim of the study was to evaluate the association of echocardiographically measured epicardial fat thickness (EFT) and inflammation, on the basis of c-reactive protein (CRP) and neutrophil-lymphocyte ratio (NLR), with MetS and its components in people with obesity.
A total of 104 patients with body mass index (BMI)≥30 kg/m² were enrolled to the study. In all participants, EFT was measured with transthoracic echocardiography at end-systole. The patients were then classified into two groups according to whether they had MetS or not. EFT, clinical and biochemical parameters were compared between the two groups
Detailed description
Epicardial adipose tissue (EAT) is a kind of VAT, between the surface of the myocardium and the epicardium. It can easily be measured by standard two-dimensional (2D) echocardiography. EAT serves as an endocrin organ that secretes hormones, inflammatory cytokines and chemokines. Previous data suggests that EAT can play an active role in the development of metabolic syndrome (MetS). Previous studies have investigated the relationship between EAT/inflammatory markers and MetS/MetS components. However, there was lack of enough evidence regarding this relationship in people with obesity with or without MetS. The aim of the present study was to evaluate the association of echocardiographically measured EAT and inflammation, on the basis of c-reactive protein (CRP) and neutrophil-lymphocyte ratio (NLR), as simple and reliable indicators of inflammation, with MetS and its components in people with obesity who have similar body mass index (BMI) values. In this cross-sectional study, 104 consecutive patients with BMI ≥30 kg/m2 who presented to the 'Obesity Solution Center 'of Antalya Research and Training Hospital were included . Patients with manifest heart disease such as, coronary heart disease, cardiac failure, cardiac valve disease or arrythmia, renal failure, hepatic failure, infection, chronic systemic inflammatory disease, pulmonary disease , malignancy and inadequate transthoracic echocardiographic images were excluded. The study protocol was approved by the local ethics committee and informed consent was obtained from each subject.
Clinical information and current cardiovascular medication use were provided from each patient. Height, weight, waist circumference and hip circumference (HC) were measured when fasting and standing up with standard measuring tools. Patients were defined as having hypertension (HT) if their systolic blood pressure was >140 mmHg, their diastolic blood pressure was >90 mmHg, or they were using an antihypertensive medication. Blood samples were obtained after overnight fasting. Fasting blood glucose, urea, creatinine, total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides, CRP, fasting and postprandial insulin, C-peptid levels, vitamin D, ferritin and complete blood counts were measured using standard methods. Homeostasis model assessment of insulin resistance (HOMA-IR) was calculated using the method described by Matthews et al. NLR was defined as the log e neutrophil count/log e lymphocyte count within the peripheral blood. Patients were defined as having diabetes mellitus (DM) if they had a history of taking an oral antidiabetic or insulin medication, or if their fasting plasma glucose was ≥ 126 mg/dl. The patients were classified into two groups according to whether they had MetS or not. MetS was diagnosed according to the National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III). Epicardial fat thickness (EFT) was identified as the echo-free space in the pericardial layers on 2D echocardiography. EFT was measured on the free wall of the right ventricle at end-systole from both parasternal long axis and parasternal short axis views using the mean of three consecutive beats.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with BMI ≥30 kg/m2, >18 years old and without manifest heart disease such as, coronary heart disease, cardiac failure, cardiac valve disease or arrythmia, renal failure, hepatic failure, infection, chronic systemic inflammatory disease, pulmonary disease and malignancy
Key inclusion criteria (1 listed)
- Having body mass index ≥30 kg/m2
Key exclusion criteria (8 listed)
- Manifest heart disease ( coronary heart disease, cardiac failure, cardiac valve disease or arrythmia)
- Renal failure
- Hepatic failure
- Infection
- Chronic systemic inflammatory disease
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
Estimation of the epicardial fat thickness in the presence of metabolic syndrome in people with obesity
Time frame: 1 week
Transthoracic echocardiography was performed to all participants with body mass index > 30 kg/m2 and epicardial fat thickness was measured. Epicardial fat thickness (EFT) was identified as the echo-free space in the pericardial layers on 2D echocardiography. EFT was measured on the free wall of the right ventricle at end-systole from both parasternal long axis and parasternal short axis views using the mean of three consecutive beats The patients were classified into two groups according to whether they had MetS or not. MetS was diagnosed according to the National Cholesterol Education Programme Adult Treatment Panel III. We evaluated the difference in epicardial fat thickness according to whether having metabolic syndrome or not, regardless of body mass index.
1 secondary outcome
Estimation of inflammation in the presence of metabolic syndrome in people with obesity
Time frame: 1 week
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 21 Aug 2020.
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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.
Duygu Ersan Demirci, MD principal investigator
Antalya Research and Training Hospital
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 Metabolic Syndrome and Obesity, run by Antalya Training and Research Hospital 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 1 inclusion and 8 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 21 Aug 2020. 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?
Estimation of the epicardial fat thickness in the presence of metabolic syndrome in people with obesity (time frame: 1 week). 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 21 Aug 2020.