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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This study has been withdrawn prior to enrollment.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
  Purpose
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: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IV Study of Surgical Treatment of Type 2 Diabetes in Non-Morbidly Obese Patients

Resource links provided by NLM:


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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00596973


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

Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT00596973     History of Changes
Other Study ID Numbers: AS07007
First Submitted: November 28, 2007
First Posted: January 17, 2008
Last Update Posted: November 17, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases