Surgical Treatment of Type 2 Diabetes in Non-Morbidly Obese Patients

Medtronic

Status and phase: Withdrawn; Phase 4

Conditions: Diabetes

Treatments: Procedure: Surgical Treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT00596973

AS07007

Details and patient eligibility

About

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

Sex: All

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Ileal transposition with SG

Experimental group

Description:

Procedure: Surgical Treatment

Treatment:

Procedure: Surgical Treatment