Weight Loss and Type 2 Diabetes: A prospective randomised controlled trial intervention study of best practice medical management versus the additional placement of the Lap-Band System in overweight patients

Monash University0 个研究点目标入组 38 人开始时间: 2009年5月18日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1. Be between 18 and 65 years of age, 2. Have a body mass index greater than 25 and less than 30 kg/m2. 3. Have been diagnosed with type 2 diabetes in the last 5 years. 4. Be able to understand the options and study requirements and to comply with the requirements of each program. 5. Willing to be randomized.

•1.If there was lack of acceptance of the randomization process,
•2.If there were a history of previous abdominal surgery which would potentially preclude laparoscopic placement of the band.
•3.If there was a history of previous obesity surgery
•4.If there were any contraindication to LapBand (LAGB) placement.
•5.If there were medical issues which contra-indicated the application of either arm of the study. These would include; acute myocardial infarction within the past 6 months, dementia, active psychosis, concurrent experimental drug use, pregnancy or intending to conceive in the next two years, lactation, illicit drug use, excessive alcohol intake, use of drugs known to affect body composition, cytotoxic drugs, internal malignancy, or major organ failure.
•6.Systemic lupus erythematosis or other auto-immune disease.
•7.Direct hypothalamic damage as a cause of obesity.
•8.If they were unable to understand the risks, realistic benefits and compliance requirements of the Lap-Band intervention and conventional management of diabetes.
•9.The patient had type 1 diabetes or diabetes was secondary to specific diseases such as haemachromatosis or chronic pancreatitis.

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