- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00450710
Neuroendocrine Brake for Type 2 Diabetes Mellitus
August 21, 2014 updated by: Medtronic - MITG
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Goiania, Brazil
- Hospital de Especialidades
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- - 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.
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Evaluate safety and efficacy of the ileal interposition associated with a sleeve gastrectomy and the ileal interposition associated with a diverted sleeve gastrectomy.
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Secondary Outcome Measures
Outcome Measure |
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Evaluate neurohormonal effect in treating T2DM.
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Improvement or control of blood glucose levels.
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Improvement or control of comorbidities associated with T2DM.
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Hormonal effect and effect of the operations on diabetes related and total mortality.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Noreen A Gannon, Medtronic - MITG
- Principal Investigator: Aureo DePaula, MD, Hospital de Especialidades
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
March 21, 2007
First Submitted That Met QC Criteria
March 21, 2007
First Posted (Estimate)
March 22, 2007
Study Record Updates
Last Update Posted (Estimate)
August 22, 2014
Last Update Submitted That Met QC Criteria
August 21, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AS06005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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