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

This study has been terminated.
(Business Reasons)
Sponsor:
Information provided by:
Covidien
ClinicalTrials.gov Identifier:
NCT00596973
First received: November 28, 2007
Last updated: November 14, 2008
Last verified: November 2008
  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: Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Covidien:

Primary Outcome Measures:
  • Treatment sucess based on patients' glycemic control [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: January 2008
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Surgical Treatment
    Ileal transposition with sleeve gastrectomy
  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596973

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

No publications provided

Responsible Party: Ross D. Segan, MD, FACS Global Medical Director, US Surgical
ClinicalTrials.gov Identifier: NCT00596973     History of Changes
Other Study ID Numbers: AS07007
Study First Received: November 28, 2007
Last Updated: November 14, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 30, 2014