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Neuroendocrine Brake for Type 2 Diabetes Mellitus

This study has been completed.
Information provided by:
Medtronic - MITG Identifier:
First received: March 21, 2007
Last updated: August 21, 2014
Last verified: August 2014
Evaluation to determine the safety of two laparoscopic procedures to control T2DM.

Condition Intervention Phase
Diabetes Procedure: ileal interposition with a sleeve gastrectomy Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Phase IV Study of Neuroendocrine Brake Surgical Procedure for Type 2 Diabetes Mellitus

Further study details as provided by Medtronic - MITG:

Primary Outcome Measures:
  • Evaluate safety and efficacy of the ileal interposition associated with a sleeve gastrectomy and the ileal interposition associated with a diverted sleeve gastrectomy.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 40
Study Start Date: March 2006
Study Completion Date: September 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  1. - Male and female between 18 and 65 years.
  2. BMI 25.1 - 34.9.
  3. Type 2 diabetic patients on oral anti-diabetic agents and/or insulin treatment for a minimum of 12 months prior the enrollment.
  4. Diagnosis of T2DM for at least 3 years.
  5. 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.
  6. HbA1c >/ 7.5 documented for at least 3 months.
  7. Stable weight (nor significant weight change (>3%) over the 3 months prior to enrollment.
  8. 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.
  9. Ability and willingness to return for all scheduled visits and participate in recommended parameter setting and physician recommended medical/laboratory assessments.

Exclusion Criteria:

  1. Prior abdominal surgery, except laparoscopic cholecystectomy.
  2. Taking appetite suppressant.
  3. Severe eating disorders.
  4. Severe pulmonary, renal or cardiac disease.
  5. Obese due to a clinically diagnosed endocrine disorder.
  6. Subjects with impaired liver function.
  7. History of peptic ulcer disease.
  8. History of malignant disease.
  9. Use of prescription, over the counter or herbal weight loss products.
  10. Pregnant or planning on pregnancy while enrolled in study.
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Please refer to this study by its identifier: NCT00450710

Hospital de Especialidades
Goiania, Brazil
Sponsors and Collaborators
Medtronic - MITG
Study Director: Noreen A Gannon Medtronic - MITG
Principal Investigator: Aureo DePaula, MD Hospital de Especialidades
  More Information Identifier: NCT00450710     History of Changes
Other Study ID Numbers: AS06005
Study First Received: March 21, 2007
Last Updated: August 21, 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on September 21, 2017