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

Phase 4

Withdrawn

• Conditions: Diabetes
• Interventions: Procedure: Surgical Treatment

• Registration Number: NCT00596973
• Lead Sponsor: Medtronic - MITG

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-11-28
• Study Start: 2008-01
• Study First Submitted QC: 2008-01-08
• Study First Posted: 2008-01-17
• Primary Completion: 2009-01
• Study Completion: 2009-03
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-14
• Last Update Posted: 2014-11-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ileal transposition with SG	Surgical Treatment	Procedure: Surgical Treatment

Primary Outcome Measures

Name	Time	Method
Treatment sucess based on patients' glycemic control	12 Months

Trial Locations

Locations (1)

Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States