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Diabetic Nephropathies clinical trials

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NCT ID: NCT00272831 Completed - Clinical trials for Diabetes Mellitus, Type 2

The Use of Cilostazol in Patients With Diabetic Nephropathy

Start date: December 2005
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT00253786 Completed - Clinical trials for Type 2 Diabetes Mellitus

Study for the Effectiveness of Intensive Therapy Aiming at a Remission of Diabetic Nephropathy

Start date: November 11, 2005
Phase: N/A
Study type: Interventional

Study for the effectiveness of intensive therapy aiming at the remission of diabetic nephropathy

NCT ID: NCT00240019 Completed - Clinical trials for Diabetic Nephropathy

Maximizing the Benefit of Renin-Angiotensin Blocking Drugs in Diabetic Renal Disease.

Start date: December 2003
Phase: N/A
Study type: Interventional

The angiotensin converting enzyme inhibitor drugs are now standard therapy for patients with diabetic nephropathy. The hypothesis of this study is that adding a diuretic agent (furosemide) will decrease the urine protein, which is a sign of disease, more than an angiotensin converting enzyme inhibitor alone.

NCT ID: NCT00237952 Completed - Clinical trials for Diabetic Nephropathies

Environmental Exposure to Lead and Progressive Renal Insufficiency in Type II Diabetic Nephropathy

Start date: August 2005
Phase: N/A
Study type: Interventional

Background The relationship between long-term heavy lead exposure and chronic interstitial nephropathy is well recognized in the previous literatures. Several epidemiological studies have demonstrated a positive association between blood lead levels and the age related decreases of renal function in the general population and suggested that environmental low-level lead exposure may accelerate the progression of renal function in the healthy persons. In addition, previous our works suggest environmental lead exposure may correlate to progressive renal insufficiency and lead chelation therapy or repeated lead chelation may improve and slow the progressive renal insufficiency in non-diabetic patients with chronic renal diseases. However, Diabetes mellitus is increasing in prevalence worldwide and is currently estimated to affect more than 6.5 percent of the population of the United States. In addition, diabetes is the most common cause of end-stage renal disease in many countries, accounting for about 40 percent of cases. It is still unknown that the relationship between long-term environmental lead exposure and the progressive renal insufficiency in patients with type II diabetes and diabetic nephropathy. Methods Ninety patints with type II diabetes and diabetic nephropathy (serum creatinine levels between 1.5 mg per deciliter and 3.9 mg per deciliter) who have a normal body lead burden and no history of exposure to lead or other metals will be observed for 24 months. Then, about 50 subjects with high normal body lead burdens (at least 80 μg but less than 600 μg) will be randomly assigned to the study and control groups. For three months, the 25 patients in the study group will receive lead-chelation therapy with calcium disodium EDTA weekly until the body lead burden fallsl below 50 μg, and the 25 control group receive weekly placebo. During the ensuing 12 months, the renal function will be regularly followed up every 3 months and EDTA mobilization tests will be assessed every 6 months. If body lead burden of the study group patients increase more than 60μg, the chelation therapy will be performed again until their body burden are less than 60 μg. The primary end point is an increase in the serum creatinine level to 2 times the base-line value during the observation period. A secondary end point is the change in renal function during the follow up period.

NCT ID: NCT00222846 Completed - Clinical trials for Diabetes Mellitus, Type 2

Enhancing Adherence in Type 2 Diabetes: The ENHANCE Study

ENHANCE
Start date: May 2004
Phase: N/A
Study type: Interventional

This randomized study will test a behavioral intervention, based on social cognitive theory (SCT), to improve regimen adherence in three different groups of people with type 2 diabetes; (1) those with well controlled blood glucoses and no concurrent chronic renal insufficiency, (2) those with less well-controlled glucoses and no chronic renal insufficiency, and (3) those with chronic renal insufficiency regardless of glucose control. The primary aims of this study are to: (1)determine whether the intervention improves behavioral adherence to the diabetes self-management regimen including dietary adherence, physical activity, and capillary glucose self-monitoring; (2)determine whether the intervention improves clinical outcomes; (3) explore the extent to which self-efficacy is a mediator of adherence,(4) explore the extent to which the effectiveness of the intervention varies with respect to glycemic control and nephrovascular complications at baseline, and (5)explore the impact of a variety of covariates on the effectiveness of the intervention. Hypothesis #1 is that intervention group participants will perform better than attention control group participants on various measures of adherence to the diabetes management regimen. Primary adherence variables will be dietary intake, and physical activity. Hypothesis #2 is that intervention group participants will have lower HbA1c levels than attention control group participants.

NCT ID: NCT00212901 Completed - Clinical trials for Diabetic Kidney Disease

High Dose Ace Inhibitor Therapy Versus Combination of ACE and ARB Therapy

Start date: August 2004
Phase: N/A
Study type: Interventional

Investigation of wheather addition of angiotensin receptor blocker (Irbesartan) to recommended doses of angiotensin converting enzyme inhibitor (trandolapril) is more effective in decreasing amount of protein in urine in patients with diabetic kidney disease than high doses of trandolapril.

NCT ID: NCT00171600 Terminated - Hypertension Clinical Trials

Antialbuminuric Effects of Valsartan and Lisinopril

Start date: July 2005
Phase: Phase 4
Study type: Interventional

Title: Antialbuminuric effect of valsartan, lisinopril and valsartan versus lisinopril in non-diabetic and diabetic renal disease: a randomized (3:3:1), open label, parallel group, 20 weeks follow-up. Objective: To evaluate the antialbuminuric effect of high doses of valsartan vs lisinopril vs combo treatment in non-diabetic and diabetic patients. Hypothesis: Combo treatment reduces microalbuminuria and the albumin/creatinine ratio more than monotherapies.. Design: Multicentric, randomized, open label, parallel group, active controlled. Dose / regimen: Valsartan 320 vs Lisinopril 40 vs Valsartan/lisinopril 160/20 Primary Endpoint: Antialbuminuric effect of valsartan 320 mg, lisinopril and valsartan versus lisinopril 40 mg in non-diabetic and diabetic renal disease following 5 months of follow-up. Description % of change in albuminuria from baseline at 20 weeks. Secondary Endpoint : To investigate the effect of 5 months treatment with valsartan,lisinopril and valsartan versus lisinopril in GFR (Cl creatinine), also to investigate the effect of 5 months treatment with valsartan, lisinopril and valsartan plus lisinopril on blood pressure and the effect on left ventricular mass index using electrocardiogram and Cornell-Sokolow method.

NCT ID: NCT00171574 Completed - Hypertension Clinical Trials

Antiproteinuric Effect of Valsartan and Lisinopril

Start date: November 2004
Phase: Phase 4
Study type: Interventional

Title: Antiproteinuric effect of valsartan, lisinopril and valsartan versus lisinopril in non-diabetic and diabetic renal disease: a randomized (3:3:1), double blind, parallel group, controlled trial, 5 months follow-up. Objective: To evaluate the antiproteinuric effect of high doses of valsartan vs combo treatment in no-diabetic and diabetic patients. Hypothesis: Combo treatment reduces microalbuminuria, proteinuria and the albumin/creatinin ratio more than monotherapies. Design: Multicentric, randomized, double blind, parallel group, active controlled. Dose / regimen Valsartan 320 vs Lisinopril 40 vs Valsartan/lisinopril 160/20

NCT ID: NCT00171119 Terminated - Hypertension Clinical Trials

A Study in Patients With Diabetes Mellitus Type II of the Effect on Albuminuria of 24 Week Treatment With Valsartan, Benazepril, and Valsartan+Benazepril

Start date: January 2004
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the efficacy of valsartan, benazepril or the combination of both in reduction of microalbuminuria in Type 2 diabetic patients.

NCT ID: NCT00168857 Completed - Hypertension Clinical Trials

A Prospective, Randomised, Double-blind, Double-dummy, Forced-titration, Multicentre, Parallel Group, One Year Treatment Trial to Compare Telmisartan (MICARDIS) 80 mg Versus Losartan (COZAAR) 100 mg, in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy (AMADEO Study)

Start date: July 9, 2003
Phase: Phase 4
Study type: Interventional

A number of blood pressure lowering drugs in the class known as angiotensin receptor blockers (ARB) have been shown to slow the decline in kidney function of patients with type 2 diabetes, high blood pressure, and kidney disease. Losartan (COZAAR), is one such drug. The purpose of this research study is to determine if after one year of treatment telmisartan (MICARDIS, GLIOSARTAN, KINZAL, KINZALMONO, PREDXAL, PRITOR, SAMERTAN, TELMISARTAN) 80 mg, another blood pressure lowering drug from the ARB class, is as effective as losartan (COZAAR) 100 mg in reducing the level of urinary protein (indicative of improved kidney function).