DiabetesPhase 4NCT00456352
Duodenal Exclusion for the Treatment of T2DM
A Phase 4 study testing duodenal exclusion in people with Diabetes, run by Medtronic - MITG at 1 site in Brazil.
Trial summary
Evaluation of duodenal exclusion procedure for the treatment of T2DM Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- duodenal exclusion
- Type of treatment
- Surgery or procedure
- How many people
- 37 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2007to Oct 2010
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 20 and 65 years
- BMI between 23 and 34
- Oral agents or insulin to control T2DM
- Inadequate control of diabetes as defined as HbA1c >/ 7.5
- Understanding of the mechanisms of action of the treatment
Who cannot join
- More than 10 years of T2DM diagnosis
- More than 7 years of insulin use
- Previous abdominal operations
- Coagulopathy
- Liver cirrhosis
- Unable to comply with study requirements, follow-up schedule or give valid consent.
- Currently pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IV Study of Duodenal Exclusion for the Treatment of Type 2 Diabetes Mellitus (T2DM)
Evaluation of duodenal exclusion procedure for the treatment of T2DM
- Conditions
- Diabetes
- Being tested
- duodenal exclusion
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duodenal exclusionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success based on patients' glycemic control.
Measured: 2 weeks, 3 months, 6 months, 9 months, 12 months
Secondary outcomes (1)
Physiologic measurements, Comorbidity improvement, Improvement in QOL.
Measured: 2 weeks, 3 months, 6 months, 9 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionApr 2009
- Study completionOct 2010
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Noreen A Gannon, Study director, Medtronic - MITGRicardo Cohen, MD, Principal investigator, Hospital São Camilo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00456352
- Sponsor's protocol ID
- AS07004
- Status last verified
- Aug 2014
- First submitted
- 2 Apr 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 Duodenal Exclusion for the Treatment of Type 2 Diabetes Mellitus (T2DM)
- ClinicalTrials.gov ID
- NCT00456352
- Acronym / sponsor ID
- AS07004
- Conditions
- Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 4 Apr 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 of duodenal exclusion procedure for the treatment of T2DM
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 20 and 65 years
- BMI between 23 and 34
- Oral agents or insulin to control T2DM
- Inadequate control of diabetes as defined as HbA1c >/ 7.5
- Understanding of the mechanisms of action of the treatment
Key exclusion criteria (7 listed)
- More than 10 years of T2DM diagnosis
- More than 7 years of insulin use
- Previous abdominal operations
- Coagulopathy
- Liver cirrhosis
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 |
|---|---|---|
| duodenal exclusion | Procedure or surgery | – |
Primary outcome
Treatment success based on patients' glycemic control.
Time frame: 2 weeks, 3 months, 6 months, 9 months, 12 months
1 secondary outcome
Physiologic measurements, Comorbidity improvement, Improvement in QOL.
Time frame: 2 weeks, 3 months, 6 months, 9 months, 12 months
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.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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
Ricardo Cohen, MD principal investigator
Hospital São Camilo
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 duodenal exclusion 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 5 inclusion and 7 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?
Treatment success based on patients' glycemic control. (time frame: 2 weeks, 3 months, 6 months, 9 months, 12 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 22 Aug 2014.