Chronic kidney disease (CKD) is a growing epidemic affecting 10% of the population worldwide. Significantly, diabetic kidney disease (DKD) is the main cause of CKD and affects approximately 40% of patients with diabetes. Approximately 10% of patients with early-stage CKD and approximately half of patients with advanced-stage CKD suffer progression to renal failure and require dialysis or transplantation to survive. Moreover, DKD progresses particularly rapidly and has a poor prognosis, accounting for almost 50% of end-stage renal disease (ESRD) cases. Dialysis in particular is a burdensome therapy associated with poor patient outcomes and high societal and economic costs. Clinical studies using RIP have demonstrated protection against ischemic target renal damage in a variety of acute and chronic clinical settings . In the renal setting, RIP performed in dialysis patients is known to abrogate brain, heart and liver ischemia occurring during hemodialysis treatments. RIP may play a role in reducing the incidence of cardiac surgery-associated acute kidney injury. However, whether RIP can improve the renal function of patients with DKD is unclear and is worthy of further study.
Our overarching hypothesis is that RIP, performed in DKD patients, could delay progression to renal failure by abrogating progressive ischemic damage in the failing kidney. The present proposal is a pilot study addressing this hypothesis and is aimed at generating proof-of-concept and feasibility data on the benefits of RIP in patients with DKD.
History of type 2 diabetes and receiving at least 1 antidiabetic medication
CKD at stage G3 or G4 (eGFR = 15-60 mL/min/1.73 m2)
UACR ≥ 300 mg/g or urinary albumin excretion rate (UAER) ≥ 300 mg/24 h
Patients are cognitively and physically capable and willing to interact with the device and perform self-measurements
Patients with New York Heart Association Class III or IV congestive heart failure at enrollment
Patients with severe illness with an expected lifespan of less than 6 months
Patients with a recent history (< 6 months) of continuous renal replacement therapy, malignant tumor, myocardial infarction, acute coronary syndrome, stroke, seizure, thrombotic/thromboembolic event (e.g., deep vein thrombosis or pulmonary embolism), or a cerebrovascular accident
Patients with known severe arterial disease of the extremities (ulcers, amputations, known symptomatic peripheral arterial disease)
Parallel
Remote ischemic conditioning
DeviceRIC is a non-invasive therapy that performed by an electric auto-control device with cuff placed on arm. RIC procedures consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on bilateral arm. The procedure will be performed twice daily for consecutive 6 months after enrollment.
Sham remote ischemic conditioning
DeviceSham RIC will be performed by the same electric auto-control device with cuff placed on arm. Sham RIC procedures consist of five cycles of 5-min inflation (60 mmHg) and 5-min deflation of cuff on bilateral arm. The procedure will be performed twice daily for consecutive 6 months after enrollment.
Standard medication therapy
DrugStandard medication therapy will be performed according to the national and international guidelines.
The tolerability of RIC in patients with DKD
Patients who complete at least of twice a day up to 5 months of RIC treatment are considered to be tolerable of RIC.
ΔSerum creatinine
Changes of serum creatinine before and after the intervention. Serum creatinine is one of biomarkers of CKD progression, which is tested in fasting serum.
ΔSerum Cystatin C
Changes of serum Cystatin C before and after the intervention. Serum Cystatin C is one of biomarkers of CKD progression, which is tested in fasting serum.
ΔHemoglobin
Changes of hemoglobin before and after the intervention. Hemoglobin is used to evaluate renal anemia in CKD patients.
ΔSerum KIM-1
Changes of serum KIM-1 before and after the intervention. Serum kidney injury molecule-1 (KIM-1) is the biomarker of renal tubule injury.
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