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A large number of research studies on people who were morbidly obese (extremely overweight), and had bariatric surgery (anti-obesity surgery) have shown that patients who were diabetic before surgery often experienced significant improvement in their diabetes following the surgery. For some patients, blood glucose levels returned to the normal range, and they were able to stop taking all of their diabetes medications. For others, blood glucose levels improved, allowing them to reduce their diabetes medications.
This research study is being done to determine whether bariatric surgery can safely provide better control of diabetes symptoms in obese diabetics than continuing medical management (anti-diabetic drugs in combination with diet and lifestyle changes).
There are several different types of bariatric surgery currently being used to treat morbid obesity. Two of the most common techniques are gastric bypass and adjustable gastric banding. This study will be comparing these two surgical techniques to treatment with a combination of drugs, diet, and lifestyle changes for control of type 2 diabetes.
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Inclusion criteria
Residents of Southern Ontario, Canada
Obese (BMI 30 to < 40 kg/m2) patients who have had type 2 diabetes mellitus for more than 5 years, complicated by at least one of the following situations that persist despite adequate management efforts. The complicating situations are:
Despite efforts at optimal glucose control, progressive secondary complications of diabetes as defined by:
Exclusion criteria
Less than 18 years of age or greater than 65 years of age
Unable to complete self and interviewer administered questionnaires in English
Incapable of providing informed consent
Any of the following medical conditions that may be associated with DM:
History of any psychiatric illness that would make the patient a poor candidate for bariatric surgery, as determined by the study psychiatrist
If female, pregnant or planning to become pregnant within next year
Clinically important cancer history (impact on either lifespan or performance of lap. bariatric surgery)
Clinically important abdominal or thoracic surgery that would impact the performance of laparoscopic bariatric procedure
Insulin dependence for more than 10 years
American Society of Anesthesiologists' classification of 4 or higher
Severe gastrointestinal reflux disease with Grade 3 or 4 esophagitis
History of pulmonary embolism or deep vein thrombosis
Presently taking either high-dose steroids or anticoagulants
Advanced nephropathy (Stage 4 or 5 - eGFR less than 30 ml/min)
Any other condition that, in the opinion of the study surgeons, would make the patient a poor candidate for bariatric surgery
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Interventional model
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20 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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