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

This study has been terminated.

( Business Reasons )

First Received: November 28, 2007 Last Updated: November 14, 2008 History of Changes

Sponsored by:	Covidien
Information provided by:	Covidien
ClinicalTrials.gov Identifier:	NCT00596973

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 IV

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase IV Study of Surgical Treatment of Type 2 Diabetes in Non-Morbidly Obese Patients

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Obesity Surgery

U.S. FDA Resources

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:

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:

Diagnosed Type 2 Diabetes for 3 to 5 years.
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.
BMI between 25.0 and 34.4.
Stable weight as determined by no more than a 3% change in body weight in the last 3 months.
Age between 35 and 65 (both men and women will be included).
Able to provide Informed Consent.
Able to comply with follow-up procedures.

Exclusion Criteria:

Previous history of major abdominal surgery which may lead to a hostile abdomen.
Pregnancy
Patients who have an incurable malignant or debilitating disease
Serious uncorrectable impairment of coagulation (INR>1.4, PTT > + 3 secs), lungs, kidney or heart
Diagnosed severe eating disorder
Use of medication for weight loss in the last 6 months
Untreated endocrine disorder
Active peptic ulcer
Untreated H. pylori
Cognitive Impairment
Diabetic autonomic neuropathy
Symptomatic gastroparesis

Contacts and Locations

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

Study placed in the following topic categories:

Obesity
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on July 06, 2009