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Neuroendocrine Brake for Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00450710
First Posted: March 22, 2007
Last Update Posted: August 22, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medtronic - MITG
  Purpose
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

Resource links provided by NLM:


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)
  Eligibility

Information from the National Library of Medicine

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

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00450710


Locations
Brazil
Hospital de Especialidades
Goiania, Brazil
Sponsors and Collaborators
Medtronic - MITG
Investigators
Study Director: Noreen A Gannon Medtronic - MITG
Principal Investigator: Aureo DePaula, MD Hospital de Especialidades
  More Information

ClinicalTrials.gov Identifier: NCT00450710     History of Changes
Other Study ID Numbers: AS06005
First Submitted: March 21, 2007
First Posted: March 22, 2007
Last Update Posted: August 22, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases