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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00596973
• Other study ID #: AS07007
• Status: Withdrawn
• Phase: Phase 4
• First received: November 28, 2007
• Last updated: November 14, 2014
• Start date: January 2008
• Est. completion date: March 2009

Study information

• Verified date: November 2014
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

Procedure:
• Surgical Treatment
Ileal transposition with sleeve gastrectomy

Locations

Country	Name	City	State
United States	Mount Sinai School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment sucess based on patients' glycemic control		12 Months	No