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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00596973
Recruitment Status : Withdrawn (Business Reasons)
First Posted : January 17, 2008
Last Update Posted : November 17, 2014
Information provided by (Responsible Party):
Medtronic - MITG

November 28, 2007
January 17, 2008
November 17, 2014
January 2008
January 2009   (Final data collection date for primary outcome measure)
Treatment sucess based on patients' glycemic control [ Time Frame: 12 Months ]
Same as current
Complete list of historical versions of study NCT00596973 on Archive Site
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Surgical Treatment of Type 2 Diabetes in Non-Morbidly Obese Patients
Phase IV Study of Surgical Treatment of Type 2 Diabetes in Non-Morbidly Obese Patients
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
Not Provided
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Procedure: Surgical Treatment
Ileal transposition with sleeve gastrectomy
Experimental: Ileal transposition with SG
Procedure: Surgical Treatment
Intervention: Procedure: Surgical Treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2009
January 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
35 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Medtronic - MITG
Medtronic - MITG
Not Provided
Principal Investigator: Barry Salky, MD Icahn School of Medicine at Mount Sinai
Medtronic - MITG
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP