Clinica San'Ambrogio
Milan, 20100, Italy
NCT Number: NCT03273621
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.
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Notify Me18 year–65 year
All sexes
Observational
Milan, 20100, Italy
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
One of two different types of surgery: sleeve gastrectomy and Roux-en-Y gastric by-pass.
Time frame: Immediately after MRI
The EAT volume will be measured in ml by manul segmentation of magnetic resonance images
Time frame: Immediately after MRI
The EAT maximal thickness will be measured in mm by using an electronic caliper on magnetic resonance images
IRCCS Policlinico S. Donato
Other
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
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