Status:
COMPLETED
Advanced Medical Therapy Versus Advanced Medical Therapy Plus Bariatric Surgery for the Resolution of Type 2 Diabetes
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
Ethicon Endo-Surgery
LifeScan
Conditions:
Diabetes Mellitus, Type 2
Obesity
Eligibility:
All Genders
20-60 years
Phase:
NA
Brief Summary
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 (...
Eligibility Criteria
Inclusion
- Type 2 diabetes mellitus with HbA1c \> 7.0%
- Body mass index \> 27 and \< 43 kg/m2
- Candidate for general anesthesia
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00432809
Start Date
February 1 2007
End Date
September 1 2016
Last Update
August 23 2017
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195