ObesityNCT03273621
Bariatric Surgery and Epicardial Adipose Tissue: a MRI Study
An observational study of Obesity, run by IRCCS Policlinico S. Donato at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Bariatic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 28 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2017to 31 Dec 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Obese patients
Who may be able to join
- patients with bariatric surgery
- informed written consent
- between the ages of 18 and 65
- patients with body mass index (BMI) ≥ 40 kg / m2
- 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.)
- 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).
Who cannot join
- lack of informed written consent
- presence of known ischemic or valvular heart disease
- pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- 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).
- performing axial MRI scans without contrast medium at the IV lumbar vertebra for quantification of abdominal and subcutaneous adipose tissue;
- direct detection of anthropometric indexes (weight, height, abdominal circumference, hip circumference);
- measurement of systolic and diastolic blood pressure with sphygmomanometer;
- 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.
- Conditions
- Obesity
- Being tested
- Bariatic surgery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatic surgeryProcedure or surgery
One of two different types of surgery: sleeve gastrectomy and Roux-en-Y gastric by-pass.
| Study group | Role | What they receive |
|---|---|---|
| Obese | Patients with a body mass index larger than 35 kg/m2 Receives: Procedure: Bariatic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
EAT volume
The EAT volume will be measured in ml by manul segmentation of magnetic resonance images
Measured: Immediately after MRI
EAT thickness
The EAT maximal thickness will be measured in mm by using an electronic caliper on magnetic resonance images
Measured: Immediately after MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start1 Jun 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Sardanelli, IRCCS Policlinico S. Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03273621
- Sponsor's protocol ID
- EAT-BS _01
- Status last verified
- Sep 2022
- First submitted
- 10 Jul 2017
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03273621
- Acronym / sponsor ID
- EAT-BS _01
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 6 Sep 2017 (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.
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.
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:
- 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).
- performing axial MRI scans without contrast medium at the IV lumbar vertebra for quantification of abdominal and subcutaneous adipose tissue;
- direct detection of anthropometric indexes (weight, height, abdominal circumference, hip circumference);
- measurement of systolic and diastolic blood pressure with sphygmomanometer;
- 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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese | – | Procedure: Bariatic surgeryPatients with a body mass index larger than 35 kg/m2 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obese patients
Key inclusion criteria (6 listed)
- patients with bariatric surgery
- informed written consent
- between the ages of 18 and 65
- patients with body mass index (BMI) ≥ 40 kg / m2
- 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.)
Key exclusion criteria (3 listed)
- lack of informed written consent
- presence of known ischemic or valvular heart disease
- pregnant women
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 |
|---|---|---|
| Bariatic surgeryOne of two different types of surgery: sleeve gastrectomy and Roux-en-Y gastric by-pass. | Procedure or surgery | Obese |
Primary outcome
EAT volume
Time frame: Immediately after MRI
The EAT volume will be measured in ml by manul segmentation of magnetic resonance images
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
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 13 Sep 2022.
- Individual participant dataSharing planned: Undecided
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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 Obesity, run by IRCCS Policlinico S. Donato at 1 site in Italy.
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 6 inclusion and 3 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 13 Sep 2022. 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 Italy. 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?
EAT volume (time frame: Immediately after MRI). The study lists 2 primary outcomes in all. 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 13 Sep 2022.