Surgical Treatment of Type 2 Diabetes in Non-Morbidly Obese Patients
Withdrawn before enrolling · Phase 4
Conditions studied: Diabetes
In brief
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
Key facts
- Study ID
- NCT00596973
- Run by
- Medtronic - MITG
- People needed
- 0
- Starts
- 2008-01-01
- Expected to finish
- 2009-03-01
- Last updated by the study team
- 2014-11-17
Who can join
Age: 35 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Mount Sinai School of Medicine — New York, New York, United States
Full record on ClinicalTrials.gov
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