Effects of Time-restricted Feeding on Obese Patients With Chronic Kidney Disease Stage 3-4: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change in eGFR (ml/min/1.73m2)
研究概览
简要总结
Obesity is associated with glomerular hyperfiltration leading to renal impairment and is a risk factor for the progression of kidney disease.Weight loss can reduce proteinuria and improve eGFR.Intermittent fasting is safe and effective, and in addition to improving body shape and weight in obese patients, it can also improve glucolipid metabolism, reduce proteinuria, improve kidney function and delay the progression of kidney disease.
详细描述
KDOQI clinical practice guideline for nutrition in chronic kidney disease (CKD) uses a low-protein diet to reduce renal impairment and delay progression. The current research hotspot is dietary intervention. Time-restricted feeding was used to intervene in the progression of CKD. It restrict the time of eating but not the eaten calories, which have a higher compliance and safety. Studies have shown that intermittent fasting in obese patients with CKD is not only reduce body weight, but also improves glycolipid metabolism, reduces proteinuria and delays the progression of kidney disease. Intermittent fasting is currently a scientific research hotspot, and there are few international studies on the implementation of intermittent fasting to delay the deterioration of renal function in obese CKD patients, and lack of data on Chinese patients, which has great research potential. Based on the above background, this study was conducted as an pilot clinical trial to explore the effects of intermittent fasting on obese patients with CKD and to observe its effectiveness, safety and compliance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years
- •CKD stage 3-4 and not on dialysis (eGFR: 15-59ml/min/1.73m2)
- •BMI ≥ 25 kg/m2
- •Good reading and comprehension skills, simple smartphone operation and no communication difficulties
- •Signed informed consent
排除标准
- •Pregnant and breastfeeding
- •End-stage diseases
- •Acute and active diseases such as gastrointestinal bleeding or acute infections, serious decompensation with diseases such as cirrhosis decompensation stage, malignant tumor, serious heart and lung diseases, severe primary diseases of hematopoietic system, severe hypertension (systolic blood pressure ≥200mmHg, diastolic blood pressure ≥120mmHg) and difficult to control blood pressure, within 3 months after major surgery, such as open surgery
- •Mental patients
- •Using medium-high doses of hormones and immunosuppressants
- •Participating in other researchers
- •Taking other dietary therapies, undergoing weight loss treatment
- •Vegetarian
- •Type 1 diabetes and type 2 diabetes using insulin
结局指标
主要结局
Change in eGFR (ml/min/1.73m2)
时间窗: 12 weeks
eGFR at final visit - eGFR at initial visit
次要结局
- Change in body mass index (kg/m2)(12 weeks)
- Changes in serum low density lipoprotein cholesterol levels (mmol/L)(12 weeks)
- Changes in serum high density lipoprotein cholesterol levels (mmol/L)(12 weeks)
- Changes in serum albumin (g/L)(12 weeks)
- Changes in body weight (Kilograms)(12 weeks)
- Changes in serum total cholesterol levels (mmol/L)(12 weeks)
- Changes in serum triglyceride levels (mmol/L)(12 weeks)
- Changes in soft lean mass (kg)(12 weeks)
- Changes in total serum protein (g/L)(12 weeks)
- Changes in proteinuria creatinine ratio (g/g)(12 weeks)
- Changes in total urine urea in 24 hours (mmol/24h)(12 weeks)
- Changes in tumor necrosis factor-α (pg/mL)(12 weeks)
- Changes in species of intestinal flora(12 weeks)
- Changes in waist circumference (cm)(12 weeks)
- Changes in fasting blood glucose (mmol/L)(12 weeks)
- Changes in interleukin-6 (pg/mL)(12 weeks)
- Changes in fat free mass (kg)(12 weeks)
- Changes in body fat mass (kg)(12 weeks)
- Changes in percent body fat (%)(12 weeks)
- Changes in arm circumference (cm)(12 weeks)
- Changes in grip strength (kg)(12 weeks)
- Changes in serum uric acid (umol/L)(12 weeks)
- Changes in serum cystatin C (mg/L)(12 weeks)
- Changes in waist-hip ratio(12 weeks)
- Changes in visceral fat area (cm2)(12 weeks)
- Changes in triceps skin fold thickness (cm)(12 weeks)
- Changes in serum creatinine (umol/L)(12 weeks)
- Changes in blood urea nitrogen (mmol/L)(12 weeks)
- Changes in C-reactive protein (mg/L)(12 weeks)
研究者
Liu Xu-sheng
Head of Nephrology, Director, Principal Investigator, Clinical Professor
Guangdong Provincial Hospital of Traditional Chinese Medicine