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临床试验/ACTRN12605000284662
ACTRN12605000284662已完成未知

A prospective observational study of the effect of a pre-operative 12 week very low calorie diet (VLCD) on liver volume and intra-abdominal fat mass in severely obese patients presenting for obesity surgery.

Centre for Obesity Research and Education (CORE)0 个研究点目标入组 40 人开始时间: 2005年9月2日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
40

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
18 Years 至 60 Years(—)
性别
All

入选标准

  • Have body weight less than 150kg and stable within ±5kg over the previous 3 months, have a pre-operative body mass index greater than 50kg/m2 for women or greater than 40kg/m2 for men or of lower BMI if they fulfill the criteria for a diagnosis of the metabolic syndrome by having 3 or more of the following: waist circumference women >88cm, men>102cm, serum triglycerides>1.69mmol/L, HDL-cholesterol women <1.29mmol/L, men<1.04mmol/L, blood pressure >130/85,FBG>6.1mmol/L, be able to understand and agree to comply with the requirements of the VLCD and monitoring over the 12 weeks, be able to provide informed consent to participate in the study.

排除标准

  • Medical contra-indications for use of a VLCD (based on the Optifast VLCD treatment protocol, May 2003) which include: pancreatitis, severe hepatic disease, advancing renal disease, pregnancy and lactation, acute cerebrovascular or cardiovascular disease, overt psychosis, type 1 diabetes, porphyria, inability to complete the 12-week VLCD program and monitoring requirements, inability to understand the requirements for optimal effectiveness of VLCD.

研究者

发起方
Centre for Obesity Research and Education (CORE)

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