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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This study has been withdrawn prior to enrollment.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:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT00596973
First received: November 28, 2007
Last updated: November 14, 2014
Last verified: November 2014

November 28, 2007
November 14, 2014
January 2008
January 2009   (final data collection date for primary outcome measure)
Treatment sucess based on patients' glycemic control [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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Withdrawn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
Both
35 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00596973
AS07007
Yes
Covidien
Covidien
Not Provided
Principal Investigator: Barry Salky, MD Mount Sinai School of Medicine
Covidien
November 2014

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