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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This study has been withdrawn prior to enrollment.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)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00596973
First Posted: January 17, 2008
Last Update Posted: November 17, 2014
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.
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 ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
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)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00596973
AS07007
Yes
Not Provided
Not Provided
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