Diabetic Nephropathy Type 2
Conditions
Keywords
Diabetic Nephropathies, Extracorporeal low intensity shockwave therapy, Proteinuria
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)
Interventions
OTHERExtracorporeal 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.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| changes of proteinuria | 12 month | using spot urine albumin- and protein-creatinine ratio |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes of systolic and diastolic blood pressure | 12 month | Let patients rest for 15 mins and check blood pressure using same sphygmomanometer. |
Countries
Taiwan
Contacts
Primary ContactLung-Chih Li, MD, PhD.
Outcome results
None listed