Diabetes
Conditions
Brief summary
The aim of this study is to assess the short term success and feasibility of ileal transposition with sleeve gastrectomy in non-morbidly obese patients with poorly controlled Type 2 Diabetes Mellitus
Interventions
PROCEDURESurgical Treatment
Ileal transposition with sleeve gastrectomy
Sponsors
Medtronic - MITG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosed Type 2 Diabetes for 3 to 5 years. 2. Poorly controlled blood sugar despite standard of care\* as demonstrated by HbA1c 8-11 for at least 6 months and 3 office visits. Standard of care is based on the ADA (American Diabetes Association) guidelines which include nutrition, exercise, education, behavior modification and pharmacological treatment. A co-investigator endocrinologist will ensure that the above standard of care has been met. 3. BMI between 25.0 and 34.4. 4. Stable weight as determined by no more than a 3% change in body weight in the last 3 months. 5. Age between 35 and 65 (both men and women will be included). 6. Able to provide Informed Consent. 7. Able to comply with follow-up procedures.
Exclusion criteria
1. Previous history of major abdominal surgery which may lead to a hostile abdomen. 2. Pregnancy 3. Patients who have an incurable malignant or debilitating disease 4. Serious uncorrectable impairment of coagulation (INR\>1.4, PTT \> + 3 secs), lungs, kidney or heart 5. Diagnosed severe eating disorder 6. Use of medication for weight loss in the last 6 months 7. Untreated endocrine disorder 8. Active peptic ulcer 9. Untreated H. pylori 10. Cognitive Impairment 11. Diabetic autonomic neuropathy 12. Symptomatic gastroparesis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment sucess based on patients' glycemic control | 12 Months |
Countries
United States
Outcome results
None listed