Extracorporeal Low-intensity Shockwave in Diabetic Nephropathy

Not Applicable

• Conditions: Diabetic Nephropathy Type 2
• Interventions: Other: Extracorporeal low-intensity shockwave

• Registration Number: NCT03445247
• Lead Sponsor: Chang Gung Memorial Hospital

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 Timeline

• Status Verified: 2017-07
• Study Start: 2017-07-01
• Study First Submitted: 2018-01-29
• Study First Submitted QC: 2018-02-22
• Last Update Submitted: 2018-02-22
• Study First Posted: 2018-02-26
• Last Update Posted: 2018-02-26
• Primary Completion: 2019-06-30
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Age >18 y/o or <80 y/o
2. Diagnosed as type 2 diabetes.
3. Baseline HbA1C <7.5%
4. Baseline glomerular filtration rate (eGFR) ≧15 and <60 ml/min/1.73m2
5. Baseline urine albumin-to-creatinine ratio (UACR) >30 and <3000 mg/g
6. Subject receives ACEi or ARB for 3 months before enrollment
7. Subject is willing to sign the permit and receive 12 times shockwave therapy

Exclusion Criteria

1. Subject is pregnant or breast feeding
2. Subject has cancer or chronic inflammatory disease
3. Subject has bleeding tendency, eg thrombocytopenia, PT INR > 2.5
4. Subject has active urinary tract infection or other active infections
5. Subject's sBP>160mmHg or dBP>100mmHg
6. Subject has stroke, cardiac infection or arrhythmia in 6 months before enrollment
7. Subject has local inflammation or infection over treatment areas
8. Subject has pacemaker or other metal implants.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Extracorporeal low-intensity shockwave	No intervention, no placebo, but do the same blood tests and examinations as experiment group at the same time points
Extracorporeal low-intensity shockwave group	Extracorporeal low-intensity shockwave	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.

Primary Outcome Measures

Name	Time	Method
changes of proteinuria	12 month	using spot urine albumin- and protein-creatinine ratio
changes of estimated glomerular filtration rate	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 Outcome Measures

Name	Time	Method
changes of systolic and diastolic blood pressure	12 month	Let patients rest for 15 mins and check blood pressure using same sphygmomanometer.

Trial Locations

Locations (1)

Kaohsiung Chang-Gung Memorial Hospital; 🇨🇳 Kaohsiung, Please Select, Taiwan