Randomized Trial of Preoperative Diets Before Bariatric Surgery
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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 |
- Preoperative weight loss before bariatric surgery [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]Weight loss in kg before operation
- - 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 |
Inclusion Criteria:
- morbid obesity according to IFSO criteria
Exclusion Criteria:
- previous bariatric or gastric surgery
- severe psychiatric disorders
Contacts and Locations| Contact: Ruben Schouten, Md, PhD | schoutenruben@hotmail.com |
| Netherlands | |
| Bariatric Centre Lievensberg hospital | Not yet recruiting |
| Bergen op Zoom, Netherlands, 4624 VT | |
| Contact: Ruben Schouten, Md, PhD schoutenruben@hotmail.com | |
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 May 16, 2013