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OpenTrials
Completed

NCT Number: NCT01285791

Sonographic Evaluation of Visceral Fat After Bariatric Surgery

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hadassah Medical Organization

Jerusalem, 91120, Israel

About this study

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 in reducing the amount of the visceral fat layer . 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 bariatric 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).

Visceral fat (VF) will be defined as the depth, in centimeters, from the rectus abdominis muscle to the aorta; and subcutaneous fat (SCF) defined as the depth, in centimeters, from the skin to the rectus abdominis muscle. Results will be compared with anthropometric measures as weight and waist circumference as well as laboratory results to try and find correlation between sonographic improvement and anthropometric and laboratory improvement.

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

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 malignant comorbidity.
  • patients suffering for a morbid obesity state because of a endocrine problem such as hypothyroidism or cushing disease.

Treatment and study plan

Primary outcomes

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

    Time frame: 18 months

    morbid obese patients undergoing a type of bariatric surgery either a laparoscopic gastric banding, a laparoscopic sleeve astrectomy or a laparoscopic gastric bypass, in our department will be evaluated by ultrasound 1 day before surgery and one year after surgery to determine the amount of visceral fat layer-by centimeters- that was decreased .

Secondary outcomes

  1. Change in Glucose and Triglyceride Blood Level

    Time frame: 18 months

    finding correlation between sonographic outcome using ultrasound, as measured by the decrease in the level of visceral fat-by centimeters, weight loss and blood levels of triglycerides and glucose.

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Official study title

Sonographic Evaluation of Visceral and Subcutaneous Fat in Morbidly Obese Patients Before and After 3 Different Types of Bariatric Surgery.

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jan 28, 2011
Registry last updated
Mar 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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