Randomized Trial of Preoperative Diets Before Bariatric Surgery

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
  Purpose

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 Intervention
Morbid Obesity
Bariatric Surgery
Gastric Bypass
Dietary Supplement: Standard diet versus standard VLCD (Prodimed)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Comparison of Preoperative Diets Before Bariatric Surgery: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Lievensberg Ziekenhuis:

Primary Outcome Measures:
  • Preoperative weight loss before bariatric surgery [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Weight loss in kg before operation


Secondary Outcome Measures:
  • - 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


Estimated Enrollment: 100
Study Start Date: September 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: R. Schouten, MD, PhD, Lievensberg Ziekenhuis
ClinicalTrials.gov Identifier: NCT01652105     History of Changes
Other Study ID Numbers: rubenschouten1
Study First Received: July 25, 2012
Last Updated: August 6, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Lievensberg Ziekenhuis:
Gastric bypass
Preoperative diet
Prodimed

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

ClinicalTrials.gov processed this record on July 22, 2014