Morbid ObesityPhase 3NCT00434525
Laparoscopic Sleeve Gastrectomy With and Without Omentectomy
A Phase 3 study testing Laparoscopic restrictive procedure and Sleeve gastrectomy in people with Morbid Obesity, run by North Texas Veterans Healthcare System at 1 site in United States.
Trial summary
The investigators aim to determine the clinical and metabolic effects of sleeve gastrectomy with or without omentectomy in the treatment of morbid obesity. The investigators hypothesize that the endocrine suppression of ghrelin (appetite hormone)and resistin (insulin antagonist) provided by sleeve gastrectomy and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Laparoscopic restrictive procedure and Sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Dec 2009
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Morbidly obese VETERANS ONLY (BMI>35 with comorbidities or BMI>40)
- Age > 18
Who cannot join
- Pregnancy
- Uncontrolled medical or psychiatric conditions
- Previous bariatric procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metabolic Effects of Laparoscopic Sleeve Gastrectomy With or Without Omentectomy: Prospective Randomized Trial
- The investigators aim to determine the clinical and metabolic effects of sleeve gastrectomy with or without omentectomy in the treatment of morbid obesity.
- The investigators hypothesize that the endocrine suppression of ghrelin (appetite hormone)and resistin (insulin antagonist) provided by sleeve gastrectomy and omentectomy (omentum or intra-abdominal fat removal) will provide clinical and metabolic benefits for morbidly obese patients.
Read the detailed description
This is a phase 3 prospective randomized trial.
- Conditions
- Morbid Obesity
- Being tested
- Laparoscopic restrictive procedure, Sleeve gastrectomy
- Keywords
- Morbid obesity, Bariatric Surgery, Obesity Surgery, Omentectomy, Sleeve gastrectomy
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic restrictive procedureProcedure or surgery
Patients will receive laparoscopic sleeve gastrectomy with or without omentectomy
Sleeve gastrectomyProcedure or surgery
Sleeve gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| 1 Sleeve gastrectomy with omentectomy | Experimental | Not described Receives: Procedure: Laparoscopic restrictive procedure |
| 2 Sleeve gastrectomy | Active comparator | Not described Receives: Procedure: Sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Measured: 5 years
Secondary outcomes (2)
Metabolic outcomes
Measured: 5 years
Diabetes resolution
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2007 (estimated)
- Study startJan 2008
- Primary completionDec 2009
- Study completionDec 2009
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North Texas Veterans Healthcare System
- Sponsor type
- US federal agency
- Investigators
- Esteban Varela, MD, MPH, Principal investigator, VA North Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00434525
- Sponsor's protocol ID
- 07-011
- Status last verified
- Aug 2009
- First submitted
- 9 Feb 2007
- Last updated
- 15 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of Laparoscopic Sleeve Gastrectomy With or Without Omentectomy: Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT00434525
- Acronym / sponsor ID
- 07-011
- Conditions
- Morbid Obesity
- Keywords
- Morbid obesity, Bariatric Surgery, Obesity Surgery, Omentectomy, Sleeve gastrectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- North Texas Veterans Healthcare SystemUS federal agency
- Study start
- Jan 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 13 Feb 2007 (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.
- The investigators aim to determine the clinical and metabolic effects of sleeve gastrectomy with or without omentectomy in the treatment of morbid obesity.
- The investigators hypothesize that the endocrine suppression of ghrelin (appetite hormone)and resistin (insulin antagonist) provided by sleeve gastrectomy and omentectomy (omentum or intra-abdominal fat removal) will provide clinical and metabolic benefits for morbidly obese patients.
Detailed description
This is a phase 3 prospective randomized trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Sleeve gastrectomy with omentectomy | Experimental | Procedure: Laparoscopic restrictive procedure |
| 2 Sleeve gastrectomy | Active comparator | Procedure: Sleeve gastrectomy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Morbidly obese VETERANS ONLY (BMI>35 with comorbidities or BMI>40)
- Age > 18
Key exclusion criteria (3 listed)
- Pregnancy
- Uncontrolled medical or psychiatric conditions
- Previous bariatric procedure
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 |
|---|---|---|
| Laparoscopic restrictive procedurePatients will receive laparoscopic sleeve gastrectomy with or without omentectomy | Procedure or surgery | 1 Sleeve gastrectomy with omentectomy |
| Sleeve gastrectomySleeve gastrectomy | Procedure or surgery | 2 Sleeve gastrectomy |
Primary outcome
Weight loss
Time frame: 5 years
2 secondary outcomes
Metabolic outcomes
Time frame: 5 years
Diabetes resolution
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2009.
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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.
Esteban Varela, MD, MPH principal investigator
VA North Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Laparoscopic restrictive procedure and Sleeve gastrectomy in people with Morbid Obesity, run by North Texas Veterans Healthcare System at 1 site in United States.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 15 Dec 2009. 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 United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: 5 years). 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 15 Dec 2009.