Morbid Obesity Clinical Trial
Official title:
Comparison of Preoperative Diets Before Bariatric Surgery: a Randomized Controlled Trial
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
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment
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