Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00272831
Status:
COMPLETED
Last Update Posted:
2009-05-22
First Post:
2006-01-05
Brief Title:
The Use of Cilostazol in Patients With Diabetic Nephropathy
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
A Randomised Double-Blind Placebo-Controlled Study of Cilostazol 100 mg Twice Daily in the Treatment of Diabetic Nephropathy in Hong Kong Chinese
Status:
COMPLETED
Status Verified Date:
2009-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with type 2 diabetes have a long duration of disease for the development of complications Among all complications microangiopathic complications are major causes of mortality and morbidity in diabetic patients In Asia patients with type 2 diabetes are particularly susceptible to the development of kidney disease Patients with diabetic kidney disease have more adverse metabolic profiles and increased risk of having other complications such as blindness stroke heart attack and nerve damage than those without Despite receiving the best of care the combined event rate of death cardiovascular disease and end stage kidney disease in diabetic patients with renal impairment remained as high as 10 per year
Cilostazol reduces platelet aggregation and prevents formation of blood clots Furthermore cilostazol treatment has been shown to reduce serum triglyceride concentrations and increase HDL-cholesterol levels In this randomized placebo-controlled double-blinded study the investigators hypothesize that Cilostazol may reduce the rate of decline in renal function in Chinese patients with type 2 diabetes and mild to moderate renal impairment Sixty patients will be randomised to receive either Cilostazol 100 mg twice daily or placebo for 12 months The effect of Cilostazol on the progression of diabetic nephropathy as defined by rates of decline in glomerular filtration rate serum creatinine and urinary albumin excretion rate will be measured The results will provide additional insight on the management of diabetic kidney disease which is prevalent among Chinese diabetic patients in Hong Kong
Cilostazol reduces platelet aggregation and prevents formation of blood clots Furthermore cilostazol treatment has been shown to reduce serum triglyceride concentrations and increase HDL-cholesterol levels In this randomized placebo-controlled double-blinded study the investigators hypothesize that Cilostazol may reduce the rate of decline in renal function in Chinese patients with type 2 diabetes and mild to moderate renal impairment Sixty patients will be randomised to receive either Cilostazol 100 mg twice daily or placebo for 12 months The effect of Cilostazol on the progression of diabetic nephropathy as defined by rates of decline in glomerular filtration rate serum creatinine and urinary albumin excretion rate will be measured The results will provide additional insight on the management of diabetic kidney disease which is prevalent among Chinese diabetic patients in Hong Kong
Detailed Description:
Hypothesis
Cilostazol reduces the rate of decline in renal function in Chinese patients with type 2 diabetes and mild to moderate renal impairment secondary to diabetic nephropathy
Objectives
To assess the suppressive effect of Cilostazol on the progression of diabetic nephropathy as defined by rates of decline in glomerular filtration rate serum creatinine and urinary albumin excretion rate
The rising prevalence of diabetes in Asia imposes a heavy burden on the health care system Given the increasingly early onset of disease patients with type 2 diabetes have long duration of disease for the development of complications Among all complications microangiopathic complications are major causes of mortality and morbidity in diabetic patients In Asia patients with type 2 diabetes are particularly susceptible to the development of nephropathy Among dialysis patients the primary disease is diabetic nephropathy in about 40 to 50 of patients Despite the inhibition of the renin angiotensin system using either ACE inhibitor or AII receptor blocker ARB as well as introduction of tight glycaemic and blood pressure control the prevalence of diabetic nephropathy remains high More importantly patients with nephropathy have more adverse metabolic profiles and increased risk of having other complications such as retinopathy macrovascular diseases and neuropathy than those without Indeed according to the RENAAL Study despite receiving the best of care the combined event rate of death cardiovascular disease and end stage renal disease in diabetic patients with renal impairment remained as high as 10 per year
Cilostazol exerts antiplatelet antithrombotic and vasodilating effects by inhibiting phosphodiesterase type 3 in platelets and vascular smooth muscle cells Furthermore cilostazol treatment has been shown to reduce serum triglyceride concentrations and increase HDL-cholesterol levels In Japanese patients with type 2 diabetes cilostazol therapy was associated with regression of carotid intimal media thickness and could prevent the onset of silent brain infarction On the other hand abnormal metabolism of prostaglandins in renal glomeruli has been postulated to modulate renal haemodynamics Elevated levels of platelet-derived microparticles and soluble adhesion molecules may further contribute to the development of diabetic nephropathy Cilostazol treatment had been shown to reduce serum levels of PMP activated platelet subsets soluble adhesion molecules and urinary excretion of thromboxane B2 in patients with type 2 diabetes These changes were accompanied by a reduction in urinary albumin excretion and an increase in creatinine clearance
Cilostazol reduces the rate of decline in renal function in Chinese patients with type 2 diabetes and mild to moderate renal impairment secondary to diabetic nephropathy
Objectives
To assess the suppressive effect of Cilostazol on the progression of diabetic nephropathy as defined by rates of decline in glomerular filtration rate serum creatinine and urinary albumin excretion rate
The rising prevalence of diabetes in Asia imposes a heavy burden on the health care system Given the increasingly early onset of disease patients with type 2 diabetes have long duration of disease for the development of complications Among all complications microangiopathic complications are major causes of mortality and morbidity in diabetic patients In Asia patients with type 2 diabetes are particularly susceptible to the development of nephropathy Among dialysis patients the primary disease is diabetic nephropathy in about 40 to 50 of patients Despite the inhibition of the renin angiotensin system using either ACE inhibitor or AII receptor blocker ARB as well as introduction of tight glycaemic and blood pressure control the prevalence of diabetic nephropathy remains high More importantly patients with nephropathy have more adverse metabolic profiles and increased risk of having other complications such as retinopathy macrovascular diseases and neuropathy than those without Indeed according to the RENAAL Study despite receiving the best of care the combined event rate of death cardiovascular disease and end stage renal disease in diabetic patients with renal impairment remained as high as 10 per year
Cilostazol exerts antiplatelet antithrombotic and vasodilating effects by inhibiting phosphodiesterase type 3 in platelets and vascular smooth muscle cells Furthermore cilostazol treatment has been shown to reduce serum triglyceride concentrations and increase HDL-cholesterol levels In Japanese patients with type 2 diabetes cilostazol therapy was associated with regression of carotid intimal media thickness and could prevent the onset of silent brain infarction On the other hand abnormal metabolism of prostaglandins in renal glomeruli has been postulated to modulate renal haemodynamics Elevated levels of platelet-derived microparticles and soluble adhesion molecules may further contribute to the development of diabetic nephropathy Cilostazol treatment had been shown to reduce serum levels of PMP activated platelet subsets soluble adhesion molecules and urinary excretion of thromboxane B2 in patients with type 2 diabetes These changes were accompanied by a reduction in urinary albumin excretion and an increase in creatinine clearance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None