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Neuroendocrine Brake for Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by:
Covidien
ClinicalTrials.gov Identifier:
NCT00450710
First received: March 21, 2007
Last updated: October 16, 2009
Last verified: October 2009
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Covidien:

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00450710

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

No publications provided

ClinicalTrials.gov Identifier: NCT00450710     History of Changes
Other Study ID Numbers: AS06005
Study First Received: March 21, 2007
Last Updated: October 16, 2009
Health Authority: Brazil: National Committee of Ethics in Research

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

ClinicalTrials.gov processed this record on May 23, 2013