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

This study has been withdrawn prior to enrollment.
(Business Reasons)
Information provided by (Responsible Party):
Medtronic - MITG Identifier:
First received: November 28, 2007
Last updated: November 14, 2014
Last verified: November 2014
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

Condition Intervention Phase
Diabetes Procedure: Surgical Treatment Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IV Study of Surgical Treatment of Type 2 Diabetes in Non-Morbidly Obese Patients

Further study details as provided by Medtronic - MITG:

Primary Outcome Measures:
  • Treatment sucess based on patients' glycemic control [ Time Frame: 12 Months ]

Enrollment: 0
Study Start Date: January 2008
Study Completion Date: March 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ileal transposition with SG
Procedure: Surgical Treatment
Procedure: Surgical Treatment
Ileal transposition with sleeve gastrectomy


Ages Eligible for Study:   35 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00596973

United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Medtronic - MITG
Principal Investigator: Barry Salky, MD Icahn School of Medicine at Mount Sinai
  More Information

Responsible Party: Medtronic - MITG Identifier: NCT00596973     History of Changes
Other Study ID Numbers: AS07007
Study First Received: November 28, 2007
Last Updated: November 14, 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on July 19, 2017