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Randomized Trial of Preoperative Diets Before Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT01652105
Recruitment Status : Unknown
Verified August 2012 by R. Schouten, Lievensberg Ziekenhuis.
Recruitment status was:  Not yet recruiting
First Posted : July 27, 2012
Last Update Posted : August 7, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment
Morbid Obesity Bariatric Surgery Gastric Bypass Dietary Supplement: Standard diet versus standard VLCD (Prodimed)

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Comparison of Preoperative Diets Before Bariatric Surgery: a Randomized Controlled Trial
Study Start Date : September 2012
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Diet
New developed diet
Dietary Supplement: Standard diet versus standard VLCD (Prodimed)
Active Comparator: Prodimed
Standard VLCD
Dietary Supplement: Standard diet versus standard VLCD (Prodimed)


Outcome Measures

Primary Outcome Measures :
  1. Preoperative weight loss before bariatric surgery [ Time Frame: 2 weeks ]
    Weight loss in kg before operation


Secondary Outcome Measures :
  1. - operation time - blood loss - difficulty of procedure - short term complications - acceptance of diets according to patients [ Time Frame: 2 weeks ]
    Measured by VAS, diet books and questionnaires


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • morbid obesity according to IFSO criteria

Exclusion Criteria:

  • previous bariatric or gastric surgery
  • severe psychiatric disorders
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01652105


Contacts
Contact: Ruben Schouten, Md, PhD schoutenruben@hotmail.com

Locations
Netherlands
Bariatric Centre Lievensberg hospital Not yet recruiting
Bergen op Zoom, Netherlands, 4624 VT
Contact: Ruben Schouten, Md, PhD       schoutenruben@hotmail.com   
Sponsors and Collaborators
Lievensberg Ziekenhuis
More Information

Responsible Party: R. Schouten, MD, PhD, Lievensberg Ziekenhuis
ClinicalTrials.gov Identifier: NCT01652105     History of Changes
Other Study ID Numbers: rubenschouten1
First Posted: July 27, 2012    Key Record Dates
Last Update Posted: August 7, 2012
Last Verified: August 2012

Keywords provided by R. Schouten, Lievensberg Ziekenhuis:
Gastric bypass
Preoperative diet
Prodimed

Additional relevant MeSH terms:
Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms