Neuroendocrine Brake for Type 2 Diabetes Mellitus

Diabetes Clinical Trial

Official title:

Phase IV Study of Neuroendocrine Brake Surgical Procedure for Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00450710
• Other study ID #: AS06005
• Status: Completed
• Phase: Phase 4
• First received: March 21, 2007
• Last updated: August 21, 2014
• Start date: March 2006
• Est. completion date: September 2009

Study information

• Verified date: August 2014
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

Evaluation to determine the safety of two laparoscopic procedures to control T2DM.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2009
• Est. primary completion date: September 2008
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Procedure:
• ileal interposition with a sleeve gastrectomy

Locations

Country	Name	City	State
Brazil	Hospital de Especialidades	Goiania

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate safety and efficacy of the ileal interposition associated with a sleeve gastrectomy and the ileal interposition associated with a diverted sleeve gastrectomy.
Secondary	Evaluate neurohormonal effect in treating T2DM.
Secondary	Improvement or control of blood glucose levels.
Secondary	Improvement or control of comorbidities associated with T2DM.
Secondary	Hormonal effect and effect of the operations on diabetes related and total mortality.