Model of Intermittent Very Low Energy Diet and eXercise for Lowering BMI in Patients With CKD (MIX UP): Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Number of Adverse Events following intermittent very low energy diet
研究概览
简要总结
This study proposes to investigate the acceptability and efficacy of intermittent VLED (5:2 diet) plus exercise, compared with the investigator's established Weight Management Programme (WMP), in obese patients with CKD, using feasibility study methodology.
Patients will be invited to participate in the parallel arm, single blinded, randomised controlled feasibility study, and randomly allocated to 1 of 2 treatments for 6 months. The experimental arm involves an intermittent modified fasting regimen consisting of VLED (600 kcal/day) on 2 consecutive days, and 5 days each week on a modified diet to maintain an overall energy deficit of 600 kcal/day across the week (5:2 diet). The control arm will be the standard renal WMP with a continuous energy restricted diet aimed at reducing daily energy intake by 600 kcal/day.
The feasibility outcomes are: recruitment rate >50%; intervention retention rate at 6 months >60%; dietary intervention compliance; and weight loss. Secondary outcomes include safety, body composition, proteinuria, lipids, blood pressure, and eating desire. Measurements will be made at baseline, midpoint, and twice at endpoint.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Study outcome measures performed by assessor blinded to treatment arm
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18-75 years
- •KDIGO defined CKD (all categories)
- •BMI ≥30kg/m2
- •able to provide written informed consent in English
排除标准
- •pregnant or breastfeeding women
- •conservatively managed CKD stage 5
- •palliative or active treatment for cancer
- •unstable chronic liver disease
- •type 1 diabetes and type 2 diabetes controlled with anti-hyperglycaemic medication
- •previous bariatric surgery
- •unable to provide written informed consent
- •significant psychiatric disorder or uncontrolled depression
- •participated in a weight management drug trial in the previous 3 months
- •uncontrolled epilepsy
- •alcohol or substance abuse
结局指标
主要结局
Number of Adverse Events following intermittent very low energy diet
时间窗: 6 months
record of all adverse events including but not limited to nausea, constipation and/or diarrhoea, dehydration, hypoglycaemia, lethargy \& fatigue, headaches, gallstones and gout.
Retention rate of at least 60% in the intervention group
时间窗: 6 months
Patients attending at least 80% of monthly clinic visits, including the baseline and final study visits, and remaining compliant with the 2 consecutive days VLED throughout the 6 month intervention will be considered "completers" and count as being retained in the intervention group at 6 months.
次要结局
- Compliance with dietary intervention from dietary records(6 months)
- Body composition(6 months)
- LDL cholesterol(6 months)
- Recruitment rate of at least 50% of potential participants meeting inclusion and exclusion criteria(1 year)
- Waist circumference (cm)(6 months)
- Exercise capacity - sit to stand 60(6 months)
- Proteinuria(6 months)
- Triglycerides(6 months)
- HDL cholesterol(6 months)
- Weight change (kg)(6 months)
- Total Cholesterol(6 months)
- kidney function (eGFR ml/min CKD EPI equation)(6 months)
- Exercise capacity - 6 minute timed walk test(6 months)