Randomized Trial of Preoperative Diets Before Bariatric Surgery

Not Applicable

• Conditions: Morbid Obesity; Bariatric Surgery; Gastric Bypass
• Interventions: Dietary Supplement: Standard diet versus standard VLCD (Prodimed)

• Registration Number: NCT01652105
• Lead Sponsor: Lievensberg Ziekenhuis

Brief 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

Detailed 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 Timeline

• Study First Submitted: 2012-07-25
• Study First Submitted QC: 2012-07-25
• Study First Posted: 2012-07-27
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-06
• Last Update Posted: 2012-08-07
• Study Start: 2012-09
• Primary Completion: 2013-03
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• morbid obesity according to IFSO criteria

Exclusion Criteria

• previous bariatric or gastric surgery
• severe psychiatric disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diet	Standard diet versus standard VLCD (Prodimed)	New developed diet
Prodimed	Standard diet versus standard VLCD (Prodimed)	Standard VLCD

Primary Outcome Measures

Name	Time	Method
Preoperative weight loss before bariatric surgery	2 weeks	Weight loss in kg before operation

Secondary Outcome Measures

Name	Time	Method
- operation time - blood loss - difficulty of procedure - short term complications - acceptance of diets according to patients	2 weeks	Measured by VAS, diet books and questionnaires

Trial Locations

Locations (1)

Bariatric Centre Lievensberg hospital; 🇳🇱 Bergen op Zoom, Netherlands