Neuroendocrine Brake for Type 2 Diabetes Mellitus
Phase IV Study of Neuroendocrine Brake Surgical Procedure for Type 2 Diabetes Mellitus
1 other identifier
interventional
40
1 country
1
Brief Summary
Evaluation to determine the safety of two laparoscopic procedures to control T2DM.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 diabetes
Started Mar 2006
Longer than P75 for phase_4 diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 21, 2007
CompletedFirst Posted
Study publicly available on registry
March 22, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedAugust 22, 2014
August 1, 2014
2.5 years
March 21, 2007
August 21, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- \- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic - MITGlead
Study Sites (1)
Hospital de Especialidades
Goiânia, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Noreen A Gannon
Medtronic - MITG
- PRINCIPAL INVESTIGATOR
Aureo DePaula, MD
Hospital de Especialidades
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 21, 2007
First Posted
March 22, 2007
Study Start
March 1, 2006
Primary Completion
September 1, 2008
Study Completion
September 1, 2009
Last Updated
August 22, 2014
Record last verified: 2014-08