Use of Bioelectric Stimulation (BES) to increase serum levels of circulating Klotho protein in patients with non-dialysis dependent chronic kidney disease (CKD) compared to health individuals
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in the serum Klotho protein level
研究概览
简要总结
**Background:**Chronic kidney disease (CKD) patients have limited options for management and most progress over time to end stage renal disease (ESRD) requiring renal replacement therapy (haemodialysis) and/or renal transplantation. There is need to find alternative therapeutic and/or stabilisation options for the CKD patients to avoid the inevitable progression to ESRD. Klotho protein, is primarily produced in the kidney and serum levels are directly correlated with the renal function. Several animal models have proposed potential improvement and/or delay in deterioration of the renal function. Precise micro-current levels of bioelectric stimulation (BES) has been associated with a significant upregulation of constitutive pro-regenerative target proteins in various tissues.
Hypothesis: The BES applied to kidney and quadrÃceps muscle shall increase the in circulating serum Klotho protein as a proxy marker of renal tissue regeneration in the CKD patients not on dialysis compared to the healthy participants.
Participants: We shall recruit 40 participants; 20 patients with CKD not on dialysis and 20 healthy individuals who shall be given BES therapy twice a week (each session 45 minutes with simultaneous kidney and quadriceps stimulation).
Data collection: The participants shall be assessed at baseline and endline (after 8 weeks of BES therapy) including the physical examination, blood pressure, ECG, blood parameters (complete blood count, RFT, LFT, blood sugar), urine 24 hour protein and serum klotho protein.
Outcomes: The study shall document the changes in serum klotho protein between the baseline and endline (after 8 weeks therapy) along with the renal function (GFR and sérum creatinine), blood pressure, 6 minute walk test performance, Quality of Life and any adverse events with the BES therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18 to 65 years Any gender CKD with Glomerular Filtration Rate (GFR) between 30-50 ml per min for more than 3 months Able to read and understand the study protocol Able to attend all 16 treatment sessions No evidence of current infection on clinical assessment Able to ambulate above 300 meters in 6 minutes.
排除标准
- •Cognitive impairment that prevents conducting evaluations, as well as inability to understand and sign the informed consent form Intolerance to low level bioelectric stimulation and, or skin sensitivity change History or clinical evidence of stroke in past 6 months with residual limitation to ambulation Disabling musculoskeletal disease Uncontrolled hypertension with Systolic blood pressure greater than 180 mmHg and diastolic blood pressure greater than 100 mmHg on two measurements Grade III or IV heart failure according to NYHA or hospitalization for heart failure in past 3 months Uncontrolled diabetes fasting blood glucose more than 250 mg per dL and HgbA1C greater than 10 Unstable angina Coronary stent placement in past 3 months Acute myocardial infarction within past three months Presence of fever and, or any acute illness Active smoker Peripheral vascular disease in the lower limbs that limits ambulation less 300 meters or has rest pain Chronic obstructive lung disease that limits ambulation or need for oxygen therapy.
结局指标
主要结局
Change in the serum Klotho protein level
时间窗: 8 weeks
次要结局
- o Change in the renal function (BUN, serum creatinine) and GFR(o Change in the systolic and diastolic blood pressures)
研究者
Dr Soumya Mishra
Kalinga Institute of Medical Sciences