Diabetic Nephropathy Type 2 Clinical Trial
Official title:
Investigational and Comparative Study to Assess Safety and Effectiveness of Tadalafil and Pentoxifyllin in the Management of Diabetic Nephropathy
Verified date | May 2024 |
Source | Tanta University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this study is to investigate and compare the safety and efficacy of selective (PDE5) enzyme inhibitor; tadalafil and non selective (PDE) inhibitor; pentoxifylline in diabetic nephropathy to improve glucose metabolism, lipid profile and decrease albuminuria.
Status | Completed |
Enrollment | 90 |
Est. completion date | September 1, 2023 |
Est. primary completion date | March 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 70 Years |
Eligibility | Inclusion Criteria: - A confirmed with clinical diagnosis of T2DM with duration at least 7 years to ensure established of micro-vascular complication (DKD). - females (post-menopause), males with sufficient erectile function. - Patients on stage 3 DN with evidence of persistent micro-albuminuria. All Abnormal tests of (UACR) must be confirmed in two out of three samples collected over a 6 month period before enrolled in the study. - (urinary ACR=30-300mg/g) in 3 consecutive measurements in 6 months period despite treatment with RAAS blockade(ramipril 10 mg ) ACEI or for at least 6 months period before enrollment in the study at maximum recommended tolerated dose. Exclusion Criteria:Cardiovascular disease: angina, arrhythmias, myocardial Infarction, heart failure (NYHA II -IV), uncontrolled hypertension > (170 \100 mm Hg) severe hypotension < (90\50 mm Hg), Hearing problem, vision defect, previous episodes of retinal / cerebral hemorrhage, psychiatric disease, thyroid disorders, alcohol abuse, smoking, Hepatic insufficiency (child -Pugh class C), (ALT or AST>3N), cholestasis, history of chronic inflammatory, immunologic or malignant disease. Acute inflammation or infectious disease in the previous 3 months, taking immunosuppressive treatment, Known allergy to tadalafil or methylxanthine, Use alpha one blockers, use of anti-oxidant drugs three months before enrollment in the study ,medications strongly alter CYP3A4 inducer or inhibitor, use of nitrates, other PDEI drugs, - Renal disease (acute kidney injury, recent exposure to radio- contrast media, creatinine clearance <30 ml/ min /1.73 m2 , bleeding disorders, peptic ulcer, and stroke, Pregnancy, lactation. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of pharmacy | Tanta |
Lead Sponsor | Collaborator |
---|---|
Tanta University |
Egypt,
Rivero A, Mora C, Muros M, Garcia J, Herrera H, Navarro-Gonzalez JF. Pathogenic perspectives for the role of inflammation in diabetic nephropathy. Clin Sci (Lond). 2009 Mar;116(6):479-92. doi: 10.1042/CS20080394. — View Citation
Wada J, Makino H. Inflammation and the pathogenesis of diabetic nephropathy. Clin Sci (Lond). 2013 Feb;124(3):139-52. doi: 10.1042/CS20120198. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Urinary albumin/creatinine ratio (ACR) | Measurement of urine albumin to creatinne ratio by measurement of urine albumin using Turbidimetric immunoassay method and measurement of urine creatinnie by standard by enzymatic colorimetric methods | Change between baseline and six months after | |
Primary | Change in Hemoglobin A1c (HbA1c). | Measurement of Hemoglobin A1C using (HPLC: ion exchange chromatography) | Change between baseline and six months after | |
Primary | Change in Fasting blood glucose. | Measurement of Fasting blood glucose by using standard enzymatic colorimetric methods | Change between baseline and six months after | |
Primary | Change in Sr Cr | Measurement of serum creatinine using colorimetric technique | Change between baseline and six months after | |
Primary | Change in Creatinine clearance | Creatinine clearance was calculated by (Cockcroft-Gault Formula) | Change between baseline and six months after | |
Primary | change in 2- Hours Postprandial blood glucose | Measurement 2- Hours Postprandial blood glucose in blood using standard enzymatic colorimetric methods | Change between baseline and six months after | |
Secondary | Change in serum ((TNF-a). | Measurement of serum level of (TNF-a) by Enzyme linked immunosorbent assay (ELISA). | Change between baseline and six months after | |
Secondary | Change in Urinary NGAL (uNGAL). | Measurement of urinary Neutrophil Gelatinase-Associated Lipocalin (NGAL)using by Enzyme linked immunosorbent assay ELISA technique: | Change between baseline and six months after | |
Secondary | Change in Lipid profile (TG, LDL, and HDL). | Measurement of serum lipid profile (TC,TG,HDL,LDL)using Enzymatic Colorimetric Method | Change between baseline and six months after | |
Secondary | Change in serum malondialdehyde (MDA) . | Meaurement of serum malondialdehyde by Enzyme linked immunosorbent assay (ELISA) . | Change between baseline and six months after |
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