DiabetesNCT00534547
Duodenal Exclusion for the Treatment of Type 2 Diabetes
A study testing Duodenal Exclusion in people with Diabetes, run by Medtronic - MITG.
Trial summary
The purpose of this study is to investigate the role of an experimental surgery that may offer better short and long-term control of T2DM in select patients who have not achieved adequate blood sugar control with regular means. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Duodenal Exclusion
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 20 and 50 years old;
- BMI between 27 and 34.9;
- Oral agents or insulin to control T2DM;
- Inadequate control of diabetes as defined as HbA1c>8.0% but <10%
- Understanding of the mechanisms of action of the treatment
Who cannot join
- More than 5 years of T2DM diagnosis;
- C-peptide <1pg/ml (off insulin)
- Previous abdominal operations;
- History of gastritis
- History of GERD
- History of peptic ulcer disease
Show all 13Show fewer
- Inflammatory bowel disease
- Coagulopathy;
- Liver cirrhosis;
- Unable to comply with study requirements, follow-up schedule or give valid informed consent;
- Currently pregnant (pregnancy test required for confirmation for those of child bearing years)
- Patient is not available for programmed follow-up during the study period
- Patient is unwilling to forgo good samaritan blood donation during the study period
About this study
Official title: Phase IV Study of Duodenal Exclusion for the Treatment of Type 2 Diabetes (T2DM)
The purpose of this study is to investigate the role of an experimental surgery that may offer better short and long-term control of T2DM in select patients who have not achieved adequate blood sugar control with regular means.
- 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
duodenal-jejunal bypass
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: 12 Months
Secondary outcomes (1)
Physiologic Measurements, Comorbidity improvement, Improvement in QOL
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
Why it stopped: business reasons
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Noreen Fahey, Study director, Medtronic - MITG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00534547
- Sponsor's protocol ID
- AS07009
- Status last verified
- Jul 2015
- First submitted
- 24 Sep 2007
- Last updated
- 27 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. 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 (T2DM)
- ClinicalTrials.gov ID
- NCT00534547
- Acronym / sponsor ID
- AS07009
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: business reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- First posted
- 26 Sep 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 purpose of this study is to investigate the role of an experimental surgery that may offer better short and long-term control of T2DM in select patients who have not achieved adequate blood sugar control with regular means.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 20 and 50 years old;
- BMI between 27 and 34.9;
- Oral agents or insulin to control T2DM;
- Inadequate control of diabetes as defined as HbA1c>8.0% but <10%
- Understanding of the mechanisms of action of the treatment
Key exclusion criteria (13 listed)
- More than 5 years of T2DM diagnosis;
- C-peptide <1pg/ml (off insulin)
- Previous abdominal operations;
- History of gastritis
- History of GERD
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 Exclusionduodenal-jejunal bypass | Procedure or surgery | – |
Primary outcome
Treatment success based on patients' glycemic control
Time frame: 12 Months
1 secondary outcome
Physiologic Measurements, Comorbidity improvement, Improvement in QOL
Time frame: 12 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2015.
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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 Fahey study director
Medtronic - MITG
Questions about this trial
What is this clinical trial studying?
A study testing Duodenal Exclusion in people with Diabetes, run by Medtronic - MITG.
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 13 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: withdrawn, as of the sponsor's last update on 27 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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: 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 27 Jul 2015.