ACTRN12619000218190招募中未知
Investigating the safety of a Low Calorie Diet using Optifast as a method of weight loss in obese patients receiving dialysis therapy
adia Obeid0 个研究点目标入组 5 人开始时间: 2019年2月14日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •BMI greater or equal to 30kg/m2
- •Aged 18-65 years
- •Receiving hemodialysis for a period of >3 months
- •Documented by the NH or RMH nephrology team as ineligible for kidney transplantation due to obesity
排除标准
- •Exclusion criteria includes:
- •Subjective Global Assessment (SGA) score of B or C (moderately or severely malnourished)
- •Severe cognitive impairment (as may not be able to follow safety instructions)
- •Patients receiving peritoneal dialysis (as a significant amount of carbohydrate is absorbed from their dialysis fluid which contributes additional calories and may prevent ketosis)
- •Type 1 Diabetes (more specialised care and monitoring including the Endocrinology department would need to be established for this group)
- •Unstable Heart Failure, Ischaemic Heart Disease, Hepatic Disease, Porphyria (contraindication based on Optifast Clinical Treatment Protocol
- •Taking Lithium, Digoxin, Warfarin or Anticonvulsants (risk of negative pharmacological interactions based on Optifast Clinical Treatment Protocol )
- •Patients also ineligible for renal transplantation due to factors in addition to obesity (e.g. malignancy, uncontrolled infection, etc) that are likely to persist indefinitely
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