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Sonographic Evaluation of Visceral Fat After Bariatric Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01285791
First received: January 10, 2011
Last updated: January 27, 2011
Last verified: January 2011
History of Changes
  Purpose

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.


Condition
Morbid Obesity

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Sonographic Evaluation of Visceral and Subcutaneous Fat in Morbidly Obese Patients Before and After 3 Different Types of Bariatric Surgery.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • decrease in the visceral fat layer measured by ultrasound a day before and a year after surgery. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Change in glucose and triglyceride blood level [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 90
Study Start Date: January 2011
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
patients undergoing laparoscopic adjustable gastric banding
morbid obese patients undergoing laparoscopic adjustable gastric banding will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased.
patients undergoing laparoscopic sleeve gastrectomy
morbid obese patients undergoing laparoscopic sleeve gastrectomy will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
patients undergoing laparoscopic gastric bypass
morbid obese patients undergoing laparoscopic gastric bypass will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Morbid obese patients admitted electively to our surgery ward after receiving detailed explanation about each type of surgery and after independently choosing to undergo either a laparoscopic adjustable gastric banding, a sleeve gastrectomy or a gatsric bypass will be offered to participate in the study.

The patients must meet criteria for being morbid obese as defined as a body mass index greater than 40 kg/meter*meter or a body mass index greater than 35 with relevant comorbidities. The patients must meet other inclusion and exclusion criteria as defined below.

The patients will be offered to participate in the study regardless of their gender or race.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01285791

Contacts
Contact: Ido Mizrahi, M.D Phone: 00 972 2 5844550 idomiz17@gmail.com
Contact: : Hadas Lemberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel, 91120
Contact: Arik Tzukert, DMD     00 972 2 6776095     arik@hadassah.org.il    
Contact: : Hadas Lemberg, PhD     00 972 2 6777572     lhadas@hadassah.org.il    
Principal Investigator: Ido Mizrahi, M.D            
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Ido Mizrahi, M.D Ministry of Health, Israel
  More Information

Publications:

Responsible Party: Dr. Ido Mizrahi, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01285791     History of Changes
Other Study ID Numbers: obesity17-HMO-CTIL
Study First Received: January 10, 2011
Last Updated: January 27, 2011
Health Authority: Israel: Ministry of Health - Director General

Keywords provided by Hadassah Medical Organization:
morbid obesity
intra-abdominal visceral fat
gastric bypass
 sleeve gastrectomy
gastric banding
visceral fat

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013