Neuroendocrine Brake for Type 2 Diabetes Mellitus

Medtronic

Status and phase: Completed; Phase 4

Conditions: Diabetes

Treatments: Procedure: ileal interposition with a sleeve gastrectomy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00450710

AS06005

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)