Randomized Trial of Preoperative Diets Before Bariatric Surgery

Lievensberg Ziekenhuis

Status: Unknown

Conditions: Gastric Bypass; Bariatric Surgery; Morbid Obesity

Treatments: Dietary Supplement: Standard diet versus standard VLCD (Prodimed)

Study type: Interventional

Funder types: Other

Identifiers

NCT01652105

rubenschouten1

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• morbid obesity according to IFSO criteria

Exclusion criteria

• previous bariatric or gastric surgery
• severe psychiatric disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Diet

Experimental group

Description:

New developed diet

Treatment:

Dietary Supplement: Standard diet versus standard VLCD (Prodimed)

Prodimed

Active Comparator group

Description:

Standard VLCD

Treatment:

Dietary Supplement: Standard diet versus standard VLCD (Prodimed)