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Randomized Trial of Preoperative Diets Before Bariatric Surgery

NCT ID: NCT01652105

Last Updated: 2012-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-06-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Morbid Obesity Bariatric Surgery Gastric Bypass

Keywords

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Gastric bypass Preoperative diet Prodimed

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Diet

New developed diet

Group Type EXPERIMENTAL

Standard diet versus standard VLCD (Prodimed)

Intervention Type DIETARY_SUPPLEMENT

Prodimed

Standard VLCD

Group Type ACTIVE_COMPARATOR

Standard diet versus standard VLCD (Prodimed)

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Standard diet versus standard VLCD (Prodimed)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* morbid obesity according to IFSO criteria

Exclusion Criteria

* previous bariatric or gastric surgery
* severe psychiatric disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lievensberg Ziekenhuis

OTHER

Sponsor Role lead

Responsible Party

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R. Schouten

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bariatric Centre Lievensberg hospital

Bergen op Zoom, , Netherlands

Site Status

Countries

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Netherlands

Central Contacts

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Ruben Schouten, Md, PhD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Ruben Schouten, Md, PhD

Role: primary

Other Identifiers

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rubenschouten1

Identifier Type: -

Identifier Source: org_study_id