Morbid ObesityNCT01652105
Randomized Trial of Preoperative Diets Before Bariatric Surgery
A study testing Standard diet versus standard VLCD (Prodimed) in people with Morbid Obesity and Bariatric Surgery, run by Lievensberg Ziekenhuis at 1 site in Netherlands.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Morbid Obesity, Bariatric Surgery, Gastric Bypass
- What is being tested?
- Standard diet versus standard VLCD (Prodimed)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2012to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- morbid obesity according to IFSO criteria
Who cannot join
- previous bariatric or gastric surgery
- severe psychiatric disorders
Trial locations and contacts
1 site in 1 country.
Ruben Schouten, Md, PhD contact
Netherlands1 site
Bariatric Centre Lievensberg hospital
Bergen op Zoom, 4624 VT
Ruben Schouten, Md, PhD, schoutenruben@hotmail.com
About this study
Official title: Comparison of Preoperative Diets Before Bariatric Surgery: a Randomized Controlled Trial
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
Read the 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.
- Conditions
- Morbid Obesity, Bariatric Surgery, Gastric Bypass
- Being tested
- Standard diet versus standard VLCD (Prodimed)
- Keywords
- Gastric bypass, Preoperative diet, Prodimed
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard diet versus standard VLCD (Prodimed)Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Diet | Experimental | New developed diet Receives: Dietary Supplement: Standard diet versus standard VLCD (Prodimed) |
| Prodimed | Active comparator | Standard VLCD Receives: Dietary Supplement: Standard diet versus standard VLCD (Prodimed) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative weight loss before bariatric surgery
Weight loss in kg before operation
Measured: 2 weeks
Secondary outcomes (1)
- operation time - blood loss - difficulty of procedure - short term complications - acceptance of diets according to patients
Measured by VAS, diet books and questionnaires
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionMar 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lievensberg Ziekenhuis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, R. Schouten, Lievensberg Ziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01652105
- Sponsor's protocol ID
- rubenschouten1
- Status last verified
- Aug 2012
- First submitted
- 25 Jul 2012
- Last updated
- 7 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Preoperative Diets Before Bariatric Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01652105
- Acronym / sponsor ID
- rubenschouten1
- Conditions
- Morbid Obesity, Bariatric Surgery, Gastric Bypass
- Keywords
- Gastric bypass, Preoperative diet, Prodimed
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lievensberg ZiekenhuisUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 27 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet | Experimental | Dietary Supplement: Standard diet versus standard VLCD (Prodimed)New developed diet |
| Prodimed | Active comparator | Dietary Supplement: Standard diet versus standard VLCD (Prodimed)Standard VLCD |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- morbid obesity according to IFSO criteria
Key exclusion criteria (2 listed)
- previous bariatric or gastric surgery
- severe psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard diet versus standard VLCD (Prodimed) | Dietary supplement | Diet, Prodimed |
Primary outcome
Preoperative weight loss before bariatric surgery
Time frame: 2 weeks
Weight loss in kg before operation
1 secondary outcome
- operation time - blood loss - difficulty of procedure - short term complications - acceptance of diets according to patients
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruben Schouten, Md, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard diet versus standard VLCD (Prodimed) in people with Morbid Obesity and Bariatric Surgery, run by Lievensberg Ziekenhuis at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruben Schouten, Md, PhD (schoutenruben@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative weight loss before bariatric surgery (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2012.