Extracorporeal Low-intensity Shockwave in Diabetic Nephropathy

Diabetic Nephropathy Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03445247
• Other study ID #: 104-7771A
• Status: Recruiting
• Phase: N/A
• First received: January 29, 2018
• Last updated: February 22, 2018
• Start date: July 1, 2017
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2017
• Source: Chang Gung Memorial Hospital
• Contact: Lung-Chih Li, MD, PhD.
• Phone: 886-7-7317123
• Email: longee01[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy Type 2
• Kidney Diseases

Intervention

Other:
• Extracorporeal low-intensity shockwave
Omnispec device to give a total of 1200 shockwaves, with low energy density at 0.1 mj/mm2 and a frequency of 120 shocks/min per kidney per treatment session, totally 12 times.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang-Gung Memorial Hospital	Kaohsiung	Please Select

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes of estimated glomerular filtration rate	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	12 month
Primary	changes of proteinuria	using spot urine albumin- and protein-creatinine ratio	12 month
Secondary	changes of systolic and diastolic blood pressure	Let patients rest for 15 mins and check blood pressure using same sphygmomanometer.	12 month