Expired Study
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New York, New York 10029


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


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


Study is Available At:


Original ID:

AS07007


NCT ID:

NCT00596973


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Withdrawn


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

35 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Covidien


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Business Reasons


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety/Efficacy Study, In


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:

Actual


Overall Contact Information

Official Name:Barry Salky, MD
Principal Investigator
Mount Sinai School of Medicine

Study Dates

Start Date:January 2008
Completion Date:March 2009
Completion Type:Actual
Primary Completion Date:January 2009
Primary Completion Type:Actual
Verification Date:November 2014
Last Changed Date:November 14, 2014
First Received Date:November 28, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure:Treatment sucess based on patients' glycemic control
Time Frame:12 Months
Safety Issues:False

Study Interventions

Intervention Type:Procedure
Name:Surgical Treatment
Description:Ileal transposition with sleeve gastrectomy
Arm Name:Ileal transposition with SG

Study Arms

Study Arm Type:Experimental
Arm Name:Ileal transposition with SG
Description:Procedure: Surgical Treatment

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Covidien

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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