N/A
N=39
Sonographic Evaluation of Visceral Fat After Bariatric Surgery
Morbid Obesity
Bottom Line
View on ClinicalTrials.gov: NCT01285791 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Decrease in the Visceral Fat Layer Measured by Ultrasound a Day Before and a Year After Surgery. — 3.6; 7.1; 5.6 visceral fat reduction in centimeters
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hadassah Medical Organization
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Decrease in the Visceral Fat Layer Measured by Ultrasound a Day Before and a Year After Surgery. |
3.6; 7.1; 5.6 | — |
| SECONDARY Change in Glucose and Triglyceride Blood Level |
— | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01285791). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.