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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet | Experimental | New developed diet |
|
| Prodimed | Active Comparator | Standard VLCD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard diet versus standard VLCD (Prodimed) | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Preoperative weight loss before bariatric surgery | Weight loss in kg before operation | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| - 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruben Schouten, Md, PhD | Contact | schoutenruben@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bariatric Centre Lievensberg hospital | Bergen op Zoom | 4624 VT | Netherlands |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |