Bariatric Surgery and Epicardial Adipose Tissue: a MRI Study
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
1 other identifier
observational
28
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2017
Longer than P75 for all trials
1 active site
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
June 1, 2017
CompletedFirst Submitted
Initial submission to the registry
July 10, 2017
CompletedFirst Posted
Study publicly available on registry
September 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedSeptember 13, 2022
September 1, 2022
4.6 years
July 10, 2017
September 12, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
EAT volume
The EAT volume will be measured in ml by manul segmentation of magnetic resonance images
Immediately after MRI
EAT thickness
The EAT maximal thickness will be measured in mm by using an electronic caliper on magnetic resonance images
Immediately after MRI
Study Arms (1)
Obese
Patients with a body mass index larger than 35 kg/m2
Interventions
One of two different types of surgery: sleeve gastrectomy and Roux-en-Y gastric by-pass.
Eligibility Criteria
Obese patients
You may qualify if:
- 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).
You may not qualify if:
- lack of informed written consent
- presence of known ischemic or valvular heart disease
- pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinica San'Ambrogio
Milan, 20100, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Radiology Department
Study Record Dates
First Submitted
July 10, 2017
First Posted
September 6, 2017
Study Start
June 1, 2017
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
September 13, 2022
Record last verified: 2022-09