NCT01285791

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2011

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 28, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

March 16, 2016

Completed
Last Updated

March 16, 2016

Status Verified

February 1, 2016

Enrollment Period

3 years

First QC Date

January 10, 2011

Results QC Date

February 18, 2016

Last Update Submit

February 18, 2016

Conditions

Morbid Obesity

Keywords

morbid obesityintra-abdominal visceral fatgastric bypasssleeve gastrectomygastric bandingvisceral fat

Outcome Measures

Primary Outcomes (1)

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

    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 .

    18 months

Secondary Outcomes (1)

  • Change in Glucose and Triglyceride Blood Level

    18 months

Study Arms (3)

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

Related Publications (1)

  • Del Genio F, Del Genio G, De Sio I, Marra M, Alfonsi L, Finelli C, Contaldo F, Pasanisi F. Noninvasive evaluation of abdominal fat and liver changes following progressive weight loss in severely obese patients treated with laparoscopic gastric bypass. Obes Surg. 2009 Dec;19(12):1664-71. doi: 10.1007/s11695-009-9891-x.

    PMID: 19526270BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr Ido Mizrahi
Organization
Hadassah Medical Organization
idomiz17@gmail.com
+972-2-5844550

Study Officials

  • Ido Mizrahi, M.D

    Ministry of Health, Israel

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ido Mizrahi MD

Study Record Dates

First Submitted

January 10, 2011

First Posted

January 28, 2011

Study Start

January 1, 2011

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

March 16, 2016

Results First Posted

March 16, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

not planning on sharing data

Locations

IL(1)