NCT04437979

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2020

Completed
Last Updated

August 21, 2020

Status Verified

August 1, 2020

Enrollment Period

6 months

First QC Date

June 16, 2020

Last Update Submit

August 19, 2020

Conditions

Keywords

epicardial fat thicknessmetabolic syndromeobesity

Outcome Measures

Primary Outcomes (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.

    1 week

Secondary Outcomes (1)

  • Estimation of inflammation in the presence of metabolic syndrome in people with obesity

    1 week

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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

You may qualify if:

  • \- Having body mass index ≥30 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya Research and Training Hospital

Antalya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Metabolic SyndromeObesityInflammation

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Duygu Ersan Demirci, MD

    Antalya Research and Training Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 16, 2020

First Posted

June 18, 2020

Study Start

January 1, 2019

Primary Completion

July 1, 2019

Study Completion

September 1, 2019

Last Updated

August 21, 2020

Record last verified: 2020-08

Locations