Randomized Trial of Preoperative Diets Before Bariatric Surgery

Morbid Obesity Clinical Trial

Official title: Comparison of Preoperative Diets Before Bariatric Surgery: a Randomized Controlled Trial

Status Not yet recruiting

Clinical Trial Summary

Randomized clinical trial of two preoperative diets before bariatric surgery (gastric bypass)comparing standard diet and Prodimed (VLCD) in 100 morbidly obese patients selected for a gastric bypass procedure

Clinical Trial Description

Morbid obesity, defined as a body mass index (BMI) of > 40 kg/m² or > 35 kg/m² with obesity-related comorbidities, is a rapidly growing problem in the western society. In the United States, about 6 million people currently have a BMI of > 40 kg/m² and another 10 million people have a BMI of > 35 kg/m² with comorbidities. Worldwide, the incidence of morbid obesity has doubled and about 300 million people are now obese. In the Netherlands the prevalence is less disturbing but the incidence of morbid obesity is rising progressively to 1.5% of the total population. At this moment surgical therapy is the only treatment option for these patients that results in sufficient long-term weight loss. Non-surgical approaches, like low energy diets and behavior modification, are not successful in the long-term with respect to maintaining weight loss and decreasing obesity-related comorbidities.

In order to increase weight loss and minimize complications a preoperative diet before bariatric has been advocated. However, the usual VLCD's are poorly tolerated by patients. In this study we aim to compare two preoperative diets in order to find the most suitable for this patient population. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bariatric Surgery
• Gastric Bypass
• Morbid Obesity
• Obesity, Morbid

• NCT number: NCT01652105
• Study type: Interventional
• Source: Lievensberg Ziekenhuis
• Contact: Ruben Schouten, Md, PhD
• Email: schoutenruben@hotmail.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2012
• Completion date: June 2013