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Randomized Trial of Preoperative Diets Before Bariatric Surgery

This study is not yet open for participant recruitment.
Verified August 2012 by Lievensberg Ziekenhuis
Sponsor:
Information provided by (Responsible Party):
R. Schouten, Lievensberg Ziekenhuis
ClinicalTrials.gov Identifier:
NCT01652105
First received: July 25, 2012
Last updated: August 6, 2012
Last verified: August 2012
History of Changes

July 25, 2012
August 6, 2012
September 2012
March 2013   (final data collection date for primary outcome measure)
Preoperative weight loss before bariatric surgery [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Weight loss in kg before operation
Same as current
Complete list of historical versions of study NCT01652105 on ClinicalTrials.gov Archive Site
- operation time - blood loss - difficulty of procedure - short term complications - acceptance of diets according to patients [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Measured by VAS, diet books and questionnaires
Same as current
Not Provided
Not Provided
 
Randomized Trial of Preoperative Diets Before Bariatric Surgery
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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
  • Morbid Obesity
  • Bariatric Surgery
  • Gastric Bypass
Dietary Supplement: Standard diet versus standard VLCD (Prodimed)
  • Experimental: Diet
    New developed diet
    Intervention: Dietary Supplement: Standard diet versus standard VLCD (Prodimed)
  • Active Comparator: Prodimed
    Standard VLCD
    Intervention: Dietary Supplement: Standard diet versus standard VLCD (Prodimed)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
June 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • morbid obesity according to IFSO criteria

Exclusion Criteria:

  • previous bariatric or gastric surgery
  • severe psychiatric disorders
Both
18 Years to 60 Years
No
Contact: Ruben Schouten, Md, PhD schoutenruben@hotmail.com
Netherlands
 
NCT01652105
rubenschouten1
No
R. Schouten, Lievensberg Ziekenhuis
Lievensberg Ziekenhuis
Not Provided
Not Provided
Lievensberg Ziekenhuis
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP