Diabetes
Conditions
Brief summary
Evaluation to determine the safety of two laparoscopic procedures to control T2DM.
Interventions
PROCEDUREileal interposition with a sleeve gastrectomy
Sponsors
Medtronic - MITG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate safety and efficacy of the ileal interposition associated with a sleeve gastrectomy and the ileal interposition associated with a diverted sleeve gastrectomy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Brazil
Outcome results
None listed