Advanced Medical Therapy Versus Advanced Medical Therapy Plus Bariatric Surgery for the Resolution of Type 2 Diabetes - NCT00432809-44195 (Clinical Trial 162144)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy162144.aspx
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| City: |
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Cleveland |
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State:
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OH |
| Zip Code: |
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44195 |
| Conditions: |
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Diabetes Mellitus, Type 2 - Obesity |
| Purpose: |
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The aim of the study is to compare the relative clinical outcomes between advanced medical
therapy alone or advanced medical therapy combined with bariatric surgery [either Roux-en-Y
gastric bypass (RYGBP) or laparoscopic sleeve gastrectomy] in patients with type 2 diabetes
and a body mass index (BMI) between 27 and 43 kg/m2. The study will examine the short and
long term effects of each intervention on biochemical resolution of diabetes, diabetic
complications, and end-organ damage.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Type 2 diabetes mellitus with HbA1c > 7.0%
- Body mass index > 27 and < 43 kg/m2
- Candidate for general anesthesia
Exclusion Criteria:
- Prior bariatric surgery of any kind
- Cardiovascular conditions including significant coronary artery disease, peripheral
vascular disease, uncompensated congestive heart failure, history of stroke, or
uncontrolled hypertension
- Kidney disease or chronic renal insufficiency with a creatinine level > 1.8 mg/dl
- Known history of chronic liver disease (except for NAFLD/NASH)
- Gastrointestinal disorders, malabsorptive disorders, or inflammatory bowel disease
- Psychiatric disorders including dementia, active psychosis, severe depression
requiring > 2 medications, history of suicide attempts, alcohol or drug abuse within
the previous 12 months
- Severe pulmonary disease defined as FEV1 < 50% of predicted value
- Pregnancy |
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| Study is available at: |
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Cleveland Clinic
Cleveland, OH 44195
United States
Primary Contact:
Chytaine Hall
Email: hallc1@ccf.org
Phone: 216-445-3983 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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