Surgical Treatment of Type 2 Diabetes in Non-Morbidly Obese Patients
NCT ID: NCT00596973
Last Updated: 2014-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2008-01-31
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ileal transposition with SG
Procedure: Surgical Treatment
Surgical Treatment
Ileal transposition with sleeve gastrectomy
Interventions
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Surgical Treatment
Ileal transposition with sleeve gastrectomy
Eligibility Criteria
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Inclusion Criteria
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
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
35 Years
65 Years
ALL
No
Sponsors
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Medtronic - MITG
INDUSTRY
Responsible Party
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Principal Investigators
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Barry Salky, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Mount Sinai School of Medicine
New York, New York, United States
Countries
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Other Identifiers
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AS07007
Identifier Type: -
Identifier Source: org_study_id