Advanced Medical Therapy Versus Advanced Medical Therapy Plus Bariatric Surgery for the Resolution of Type 2 Diabetes
Completed · Not applicable
Conditions studied: Diabetes Mellitus, Type 2, Obesity
In brief
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.
Key facts
- Study ID
- NCT00432809
- Run by
- The Cleveland Clinic
- People needed
- 150
- Starts
- 2007-02-01
- Expected to finish
- 2016-09-01
- Last updated by the study team
- 2017-08-23
Who can join
Age: 20 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Type 2 diabetes mellitus with HbA1c > 7.0%
- Body mass index > 27 and < 43 kg/m2
- Candidate for general anesthesia
You may not qualify if…
- 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
Where it is running
- Cleveland Clinic — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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