DiabetesPhase 3NCT00552942
Randomized Controlled Trial of Laparoscopic Gastric Bypass Plus Omentectomy Versus Laparoscopic Gastric Bypass Alone in Improving Diabetic Indices
A Phase 3 study testing laparoscopic gastric bypass plus omentectomy in people with Diabetes and Interleukins, run by Legacy Health System at 1 site in United States.
Trial summary
To see if removing the omentum in addition to a gastric bypass improves diabetes is better than just a gastric bypass. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Interleukins, Cytokines
- What is being tested?
- laparoscopic gastric bypass plus omentectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Jul 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing laparoscopic gastric bypass, >18 yo, understands english
Who cannot join
- previous lower pelvic surgery, self-pay patients, previous weight loss surgery,
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Oregon Weight Loss Surgery LLC
Portland, Oregon, 97210
Dennis Hong, MD, MS.,c, FRCSC, 503-227-5050, dennishong70@gmail.com
About this study
To see if removing the omentum in addition to a gastric bypass improves diabetes is better than just a gastric bypass.
- Conditions
- Diabetes, Interleukins, Cytokines
- Being tested
- laparoscopic gastric bypass plus omentectomy
- Keywords
- obesity, diabetes, cytokines
- Medical subject headings
- Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic gastric bypass plus omentectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | surgery plus omentectomy Receives: Procedure: laparoscopic gastric bypass plus omentectomy |
| 2 | No intervention | standard gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
diabetic indices
Measured: 6 months
Secondary outcomes (1)
interleukin and cytokine levels, weight loss
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2007 (estimated)
- Study startJul 2006
- Study completionJul 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Legacy Health System
- Sponsor type
- University, hospital or other
- Investigators
- Dennis Hong, MD., MS.c, FRCSC, Principal investigator, Oregon Weight Loss Surgery, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552942
- Sponsor's protocol ID
- 1234
- Status last verified
- Nov 2007
- First submitted
- 1 Nov 2007
- Last updated
- 2 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Laparoscopic Gastric Bypass Plus Omentectomy Versus Laparoscopic Gastric Bypass Alone in Improving Diabetic Indices
- ClinicalTrials.gov ID
- NCT00552942
- Acronym / sponsor ID
- 1234
- Conditions
- Diabetes, Interleukins, Cytokines
- Keywords
- obesity, diabetes, cytokines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Legacy Health SystemUniversity, hospital or other
- Study start
- Jul 2006
- Study completion
- Jul 2008 (estimated)
- First posted
- 2 Nov 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.
To see if removing the omentum in addition to a gastric bypass improves diabetes is better than just a gastric bypass.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: laparoscopic gastric bypass plus omentectomysurgery plus omentectomy |
| 2 | No intervention | –standard gastric bypass |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- undergoing laparoscopic gastric bypass, >18 yo, understands english
Key exclusion criteria (1 listed)
- previous lower pelvic surgery, self-pay patients, previous weight loss surgery,
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 gastric bypass plus omentectomy | Procedure or surgery | 1 |
Primary outcome
diabetic indices
Time frame: 6 months
1 secondary outcome
interleukin and cytokine levels, weight loss
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2007.
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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.
Dennis Hong, MD., MS.c, FRCSC principal investigator
Oregon Weight Loss Surgery, LLC
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 gastric bypass plus omentectomy in people with Diabetes and Interleukins, run by Legacy Health 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 1 inclusion and 1 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 2 Nov 2007. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dennis Hong, MD, MS.c, FRCSC (503-227-5050, dennishong70@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diabetic indices (time frame: 6 months). 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 2 Nov 2007.