CompletedNot Applicable

Sonographic Evaluation of Visceral Fat After Bariatric Surgery

Israel39 participantsStarted 2011-01

Plain-language summary

Excess visceral fat is a key factor in the development of metabolic syndrome associated with obesity. After bariatric surgery, patients experience weight loss accompanied by a decrease in the amount of total body fat. It is unclear how the different surgical procedures vary in their effect on the visceral and subcutaneous fat change. Ultrasonography (US) is an effective, efficient method in assessing this metabolically active layer of fat even when compared with gold standard techniques such as computed tomography and magnetic resonance imaging. Only a few studies managed to show the actual decrease in the visceral fat layer after these kinds of surgeries. The aim is to compare by ultrasound evaluation the extent of fat layers reduction after laparoscopic adjustable gastric banding (LAGB), laparoscopic sleeve gastrectomy (LSG) and laparoscopic roux-en-y gastric bypass (LRYGB). The hypothesis is that the sleeve gastrectomy and gastric bypass being not only a restrictive procedure but also a malabsorptive procedure will have the best results in decreasing the amount of visceral fat.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * age above 18 years and below 70 years * patients considered to suffer from morbid obesity as defined as a body mass index above 40 kg/meter\*meter or above 35 kg/meter\*meter with comorbidities relevant to obesity such as : diabetes, hypertension, arthralgia, obstructive sleep apnea and hyperlipidemia and eligible for surgery * patients that electively and independently chose to undergo a bariatric surgery in our surgery ward. * patients expressing their desire to participate in the study and after signing informed consent. * patients that underwent a lecture about the pros and cons of the different types of bariatric surgery performed in our surgery ward:laparoscopic adjustable gastric banding, a sleeve gastrectomy or a gastric bypass and chose independently the type of surgery they want to undergo. * patients that tried to lose weight in conventional ways such as physical activity and diets with no success. Exclusion Criteria: * patients under the age of 18 or above the age 70. * patients unable to read, understand, comprehend and sign the informed consent form. * patients not meeting the criteria for the definition morbid obesity as defined as a body mass index above 40 kg/meter\*meter or above 35 kg/meter\*meter with comorbidities relevant to obesity such as : diabetes, hypertension, arthralgia, obstructive sleep apnea and hyperlipidemia. * pregnant patients. * patients addicted to alcohol or other recreational drugs. * patients suffering from a m…

Questions worth asking your doctor

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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Decrease in the Visceral Fat Layer Measured by Ultrasound a Day Before and a Year After Surgery.

Timeframe: 18 months

Trial details

NCT IDNCT01285791

SponsorHadassah Medical Organization

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2014-01

Results submitted2016-02-18

View on ClinicalTrials.gov More Morbid Obesity trials