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

Tracking Information

First Received Date ^ICMJE

November 28, 2007

Last Updated Date

November 14, 2008

Start Date ^ICMJE

January 2008

Estimated Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00596973 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Diabetes

Intervention ^ICMJE

Procedure: Surgical Treatment

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2009

Estimated Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

35 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00596973

Responsible Party

Ross D. Segan, MD, FACS Global Medical Director, US Surgical

Study ID Numbers ^ICMJE

AS07007

Study Sponsor ^ICMJE

Covidien

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Barry Salky, MD

Mount Sinai School of Medicine

Information Provided By

Covidien

Verification Date

November 2008

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