Sonographic Evaluation of Visceral Fat After Bariatric Surgery
Sonographic Evaluation of Visceral and Subcutaneous Fat in Morbidly Obese Patients Before and After 3 Different Types of Bariatric Surgery.
Przegląd badań
Status
Warunki
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
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Jerusalem, Izrael, 91120
- Hadassah Medical Organization
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
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.
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: Tylko przypadek
- Perspektywy czasowe: Spodziewany
Kohorty i interwencje
Grupa / Kohorta |
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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.
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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
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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
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Decrease in the Visceral Fat Layer Measured by Ultrasound a Day Before and a Year After Surgery.
Ramy czasowe: 18 months
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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 .
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18 months
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change in Glucose and Triglyceride Blood Level
Ramy czasowe: 18 months
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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.
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18 months
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Ido Mizrahi, M.D, Ministry of Health, Israel
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- obesity17-HMO-CTIL
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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