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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01652105
• Other study ID #: rubenschouten1
• Status: Not yet recruiting
• Phase: N/A
• First received: July 25, 2012
• Last updated: August 6, 2012
• Start date: September 2012
• Est. completion date: June 2013

Study information

• Verified date: August 2012
• Source: Lievensberg Ziekenhuis
• Contact: Ruben Schouten, Md, PhD
• Email: schoutenruben[@]hotmail.com
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• morbid obesity according to IFSO criteria

Exclusion Criteria:

• previous bariatric or gastric surgery

• severe psychiatric disorders

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

Intervention

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

Locations

Country	Name	City	State
Netherlands	Bariatric Centre Lievensberg hospital	Bergen op Zoom

Sponsors (1)

Lead Sponsor	Collaborator
Lievensberg Ziekenhuis

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preoperative weight loss before bariatric surgery	Weight loss in kg before operation	2 weeks	No
Secondary	- operation time - blood loss - difficulty of procedure - short term complications - acceptance of diets according to patients	Measured by VAS, diet books and questionnaires	2 weeks	No