The effect of weight loss on Type 2 Diabetes: a prospective randomized controlled trial of best practice medical management versus the placement of the Lap-Band System on HbA1c concentration.

Centre for Obesity Research and Education (CORE)0 个研究点目标入组 60 人开始时间: 2005年8月16日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•Patients will have a BMI greater than 30 and less than 40kg/m2, have been diagnosed with Type 2 diabetes within the last two years, have no evidence of renal impairment, microalbuminuria or retinopathy, be able to understand the options and study requirements and to comply with the either arm of the study, and be willing to be randomized.

•Unwillingness to accept the randomization process, history of previous abdominal surgery which would potentially preclude laparascopic placement of the band, a history of previous obesity surgery, any contraindication to Lap-Band placement, medical issues which contraindicated 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, autoimmune disease, pregnancy, lactation, illicit drug use, excessive alcohol intake, use of drugs known to affect body composition, cytotoxic drugs, internal malignancy or major organ failure) , systemic lupus erythematosis or other auto-immune disease, direct hypothalamic damage as a cause of obesity, inability to understand the risks, realistic benefits and compliance requirements of the Lap-Band intervention and conventional management of diabetes, Type 1 diabetes or diabetes secondary to specific diseases foe example haemochromatosis or chronic pancreatitis.

发起方

Centre for Obesity Research and Education (CORE)