Bariatric Surgery and Epicardial Adipose Tissue: a MRI Study

September 12, 2022 updated by: Francesco Sardanelli, IRCCS Policlinico S. Donato

Effetti di Differenti Tipologie di Intervento di Chirurgia Bariatrica Sul Tessuto Adiposo Epicardico e su Alcuni Parametri Morfologici e Funzionali Cardiovascolari, Valutati Con Risonanza Magnetica Nucleare

The aim of this study is to measure the volume of the epicardial adispose tissue (EAT) and other morphological and functional cardiovascular parameters in subjects with severe obesity, using an open magnetic resonance unit capable of holding up to 220 kg of weight. These measurements will be repeated a year after bariatric surgery to assess the effect of the weight loss on EAT. The possible difference among different types of bariatric surgery will be considered.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this prospective observational study, 28 obese male and female subjects underwent bariatric surgery will be studied: 14 subjects candidates for SG and 14 at RYGB. These patients will enrolled in this type of intervention at the INCO bariatric surgery unit (National Institute for Obesity). All patients are first evaluated by a multidisciplinary team to establish adherence to the criteria suggested by the guidelines for bariatric surgery.

All enrolled subjects will be subjected to the following protocol within one month prior to surgery and one year (±1 month) after surgery:

  1. CMR without contrast medium with 1-T (Panorama, Philips) open device for the measurement of EAT volume in systoles and diastoles for the evaluation of the main morpho-functional parameters (left ventricular size and mass , Right ventricular size, atrial size, left and right ventricular systolic function, diastolic left and right ventricular function) and for evaluating the elasticity of the thoracic aortic wall, evaluated as compliance and stiffness (duration of examination About 30 minutes).
  2. performing axial MRI scans without contrast medium at the IV lumbar vertebra for quantification of abdominal and subcutaneous adipose tissue;
  3. direct detection of anthropometric indexes (weight, height, abdominal circumference, hip circumference);
  4. measurement of systolic and diastolic blood pressure with sphygmomanometer;
  5. assessment of body composition by bioimpedenzometry with estimate of fat and lean mass expressed in kg and in percentage.

The examinations will be carried out following the normal procedures provided by clinical practice and all scans performed by Magnetic Resonance will be performed at the Italian Diagnostic Center (CDI), Via Saint Bon, 20 - 20147 Milan (which has MRI equipment open). Other investigations will be carried out at the Istituto Nazionale per la cura del dono (INCO) of the Sant'Ambrogio Clinical Institute.

The sample size was calculated assuming that an average thickness of 12.3±1.8 mm (Iacobellis G. at al, 2008) is expected to reduce the thickness by approximately 30% to 4 ± 0.8 mm (from An average epicardial fat content of 137 ± 37 ml is expected to be about 30% reduction of 39 ± 12 ml). With a 90% power and alpha error of 5% (two-tailed) we have obtained a minimum number of 22 subjects. Assuming a 20% loss to follow-up, approximately 28 subjects should be recruited.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20100
        • Clinica San'Ambrogio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Obese patients

Description

Inclusion Criteria:

  1. patients with bariatric surgery
  2. informed written consent
  3. between the ages of 18 and 65
  4. patients with body mass index (BMI) ≥ 40 kg / m2
  5. patients with 35 ≤ BMI <40 kg / m2 in the presence of comorbidities that could improve or cure following the remarkable and persistent weight loss achieved with the intervention (metabolic diseases, cardiorespiratory diseases, severe joint disorders, severe psychological problems, etc.)
  6. patients with 35 ≤ BMI <40 kg / m2 with previous failure of proper medical treatment (lack or insufficient weight loss, lack or lack of long-term maintenance of weight loss).

Exclusion Criteria:

  1. lack of informed written consent
  2. presence of known ischemic or valvular heart disease
  3. pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Obese
Patients with a body mass index larger than 35 kg/m2
Procedure: Bariatic surgery
One of two different types of surgery: sleeve gastrectomy and Roux-en-Y gastric by-pass.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
EAT volume
Time Frame: Immediately after MRI
The EAT volume will be measured in ml by manul segmentation of magnetic resonance images
Immediately after MRI
EAT thickness
Time Frame: Immediately after MRI
The EAT maximal thickness will be measured in mm by using an electronic caliper on magnetic resonance images
Immediately after MRI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IRCCS Policlinico S. Donato

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EAT-BS _01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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