DiabetesPhase 4NCT00450710
Neuroendocrine Brake for Type 2 Diabetes Mellitus
A Phase 4 study testing ileal interposition with a sleeve gastrectomy in people with Diabetes, run by Medtronic - MITG at 1 site in Brazil.
Trial summary
Evaluation to determine the safety of two laparoscopic procedures to control T2DM. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes
- What is being tested?
- ileal interposition with a sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2006to Sep 2009
- Phase
- Phase 4
- 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
- Adult, Older adult
Who may be able to join
- - Male and female between 18 and 65 years.
- BMI 25.1 - 34.9.
- Type 2 diabetic patients on oral anti-diabetic agents and/or insulin treatment for a minimum of 12 months prior the enrollment.
- Diagnosis of T2DM for at least 3 years.
- Patient has been under routine care of hte study physician or another physician that can supply a reliable medical record for at least 3 years.
- HbA1c >/ 7.5 documented for at least 3 months.
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- Stable weight (nor significant weight change (>3%) over the 3 months prior to enrollment.
- Stable medication for at least one month prior to enrollment except for diabetes medications which should be stable for at least 3 months prior to enrollment.
- Ability and willingness to return for all scheduled visits and participate in recommended parameter setting and physician recommended medical/laboratory assessments.
Who cannot join
- Prior abdominal surgery, except laparoscopic cholecystectomy.
- Taking appetite suppressant.
- Severe eating disorders.
- Severe pulmonary, renal or cardiac disease.
- Obese due to a clinically diagnosed endocrine disorder.
- Subjects with impaired liver function.
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- History of peptic ulcer disease.
- History of malignant disease.
- Use of prescription, over the counter or herbal weight loss products.
- Pregnant or planning on pregnancy while enrolled in study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IV Study of Neuroendocrine Brake Surgical Procedure for Type 2 Diabetes Mellitus
Evaluation to determine the safety of two laparoscopic procedures to control T2DM.
- Conditions
- Diabetes
- Being tested
- ileal interposition with a sleeve gastrectomy
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ileal interposition with a sleeve gastrectomyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate safety and efficacy of the ileal interposition associated with a sleeve gastrectomy and the ileal interposition associated with a diverted sleeve gastrectomy.
Secondary outcomes (4)
Evaluate neurohormonal effect in treating T2DM.
Improvement or control of blood glucose levels.
Improvement or control of comorbidities associated with T2DM.
Hormonal effect and effect of the operations on diabetes related and total mortality.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2007 (estimated)
- Study startMar 2006
- Primary completionSep 2008
- Study completionSep 2009
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.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Noreen A Gannon, Study director, Medtronic - MITGAureo DePaula, MD, Principal investigator, Hospital de Especialidades
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00450710
- Sponsor's protocol ID
- AS06005
- Status last verified
- Aug 2014
- First submitted
- 21 Mar 2007
- Last updated
- 22 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of Neuroendocrine Brake Surgical Procedure for Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00450710
- Acronym / sponsor ID
- AS06005
- Conditions
- Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 22 Mar 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.
Evaluation to determine the safety of two laparoscopic procedures to control T2DM.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- - Male and female between 18 and 65 years.
- BMI 25.1 - 34.9.
- Type 2 diabetic patients on oral anti-diabetic agents and/or insulin treatment for a minimum of 12 months prior the enrollment.
- Diagnosis of T2DM for at least 3 years.
- Patient has been under routine care of hte study physician or another physician that can supply a reliable medical record for at least 3 years.
Key exclusion criteria (10 listed)
- Prior abdominal surgery, except laparoscopic cholecystectomy.
- Taking appetite suppressant.
- Severe eating disorders.
- Severe pulmonary, renal or cardiac disease.
- Obese due to a clinically diagnosed endocrine disorder.
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 |
|---|---|---|
| ileal interposition with a sleeve gastrectomy | Procedure or surgery | – |
Primary outcome
Evaluate safety and efficacy of the ileal interposition associated with a sleeve gastrectomy and the ileal interposition associated with a diverted sleeve gastrectomy.
4 secondary outcomes
Evaluate neurohormonal effect in treating T2DM.
Improvement or control of blood glucose levels.
Improvement or control of comorbidities associated with T2DM.
Hormonal effect and effect of the operations on diabetes related and total mortality.
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 22 Aug 2014.
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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.
Noreen A Gannon study director
Medtronic - MITG
Aureo DePaula, MD principal investigator
Hospital de Especialidades
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ileal interposition with a sleeve gastrectomy in people with Diabetes, run by Medtronic - MITG at 1 site in Brazil.
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 9 inclusion and 10 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 22 Aug 2014. 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 Brazil. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Evaluate safety and efficacy of the ileal interposition associated with a sleeve gastrectomy and the ileal interposition associated with a diverted sleeve gastrectomy.. 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 22 Aug 2014.