An Investigation on the Effects of Extracorporeal Low-intensity Shockwave Therapy on Protenuria, Renal Function, and Blood Pressure in Type 2 Diabetic Patients in Stage 3-4 Chronic Kidney Disease
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- changes of proteinuria
Study Overview
Brief Summary
In the current study, we use extracorporeal low-intensity shockwave therapy (ESWT) to treat on patients with type 2 diabetes in stage 3-4 chronic kidney disease and see whether it can improve the proteinuria, renal function, and blood pressure compared to baseline and control group.
Detailed Description
Diabetic nephropathy is the major contributor to end stage renal disease worldwide. Extracorporeal shock wave treatments (ESWT) with low-intensity was reported to be beneficial in inducing cell regeneration and reducing inflammation and have been successfully used for bone fracture, cardiac ischemia, and erectile disorders. In this study, sixty patients with stage III & IV (15<=estimated glomerular filtration rate (eGFR)<60 ml/min/1.73m2) will be recruited and allocated to control and experimental groups in a 1:1 ratio. In experiment group, a total of 1200 shockwaves, with low energy density 0.1mj/mm2 and a frequency of 120 shocks/min, will be applied per kidney per treatment session. The treatment will be given twice a week for 3 consecutive weeks, followed by 3 weeks of recess and an additional series of 6 sessions (totally 12 times). Patients in each group will be evaluated with eGFR, urine protein-creatinine ration, blood pressure, and biochemistry data at the beginning (index day) and 12 months after starting of the therapy. (Outcome time point: 12 months)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age >18 y/o or <80 y/o
- •Diagnosed as type 2 diabetes.
- •Baseline HbA1C <7.5%
- •Baseline glomerular filtration rate (eGFR) ≧15 and <60 ml/min/1.73m2
- •Baseline urine albumin-to-creatinine ratio (UACR) >30 and <3000 mg/g
- •Subject receives ACEi or ARB for 3 months before enrollment
- •Subject is willing to sign the permit and receive 12 times shockwave therapy
Exclusion Criteria
- •Subject is pregnant or breast feeding
- •Subject has cancer or chronic inflammatory disease
- •Subject has bleeding tendency, eg thrombocytopenia, PT INR > 2.5
- •Subject has active urinary tract infection or other active infections
- •Subject's sBP>160mmHg or dBP>100mmHg
- •Subject has stroke, cardiac infection or arrhythmia in 6 months before enrollment
- •Subject has local inflammation or infection over treatment areas
- •Subject has pacemaker or other metal implants.
Arms & Interventions
Control
No intervention, no placebo, but do the same blood tests and examinations as experiment group at the same time points
Intervention: Extracorporeal low-intensity shockwave (Other)
Extracorporeal low-intensity shockwave group
with 12 times extracorporeal low intensity shockwave therapy and do the blood test and assessments at baseline, 3, 6, 12 m after initiation of therapy.
Intervention: Extracorporeal low-intensity shockwave (Other)
Outcomes
Primary Outcomes
changes of proteinuria
Time Frame: 12 month
using spot urine albumin- and protein-creatinine ratio
changes of estimated glomerular filtration rate
Time Frame: 12 month
using Modification of Diet in Renal Disease (MDRD) equation, which is eGFR (mL/min/1.73m2) = 175 × serum creatinine-1.154 × age-0.203× 0.742 (if female) to evaluate renal function
Secondary Outcomes
- changes of systolic and diastolic blood pressure(12 month)