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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Turkey (Türkiye)

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.

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.

  1. 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)
  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.

  1. First posted18 Jun 2020
  2. Study start1 Jan 2019
  3. Primary completion1 Jul 2019
  4. Study completion1 Sep 2019

Resources

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)
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

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.

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