Diabetic Nephropathy Type 2 Clinical Trial
Official title:
Antiproteinuric Efficacy of ACE Inhibitors, Selective MRAs and ACE Inhibitor/Selective MRA Combination Therapy in Diabetic Hypertensives With Microalbuminuria
The aim of our work is to compare the antiproteinuric efficacy of ACEI monotherapy, Selective MRA monotherapy and their combination in mildly hypertensive patients with type 2 diabetes mellitus and microalbuminuria
Status | Recruiting |
Enrollment | 75 |
Est. completion date | March 2020 |
Est. primary completion date | February 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Adult male and non-pregnant female patients with established diagnosis of type 2 DM at least five years ago with glycosylated hemoglobin (HbA1c) = 8.5% - Age 30-80 Y - Stage 1 hypertension (systolic BP 140-159 mmHg and/or diastolic BP 90-99 mmHg) and microalbuminuria diagnosed by measuring Urinary albumin/creatinine ratio (UACR) . Microalbuminuria was defined at a level between (30-300 mg/g) - Patients included in our study had never been treated with ACEIs, ARBs or aldosterone antagonists, serum potassium level = 3.5 and = 5.0 mmol/L before randomization with estimated glomerular filtration rate (e GFR) =50 mL/min/1.73 m2 Exclusion Criteria: - Patients with type 1 diabetes mellitus - Patients with BP = 160/100 mmHg - Patients with secondary hypertension - Non-diabetic nephropathy including (chronic glomerulonephritis, polycystic kidney disease and nephrosclerosis), - Confirmed bilateral renal artery stenosis or stenosis of the renal artery in solitary functioning kidney - History of New York Heart Association functional class III and IV heart failure - Patients with rapid progression of kidney disease and women who were pregnant, breast-feeding, or planning to become pregnant during the study period |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Medicine,Beni-Suef University | Bani Suwayf |
Lead Sponsor | Collaborator |
---|---|
Beni-Suef University |
Egypt,
Cagnoni F, Njwe CA, Zaninelli A, Ricci AR, Daffra D, D'Ospina A, Preti P, Destro M. Blocking the RAAS at different levels: an update on the use of the direct renin inhibitors alone and in combination. Vasc Health Risk Manag. 2010 Aug 9;6:549-59. Review. — View Citation
Cao Z, Cooper ME. Pathogenesis of diabetic nephropathy. J Diabetes Investig. 2011 Aug 2;2(4):243-7. doi: 10.1111/j.2040-1124.2011.00131.x. Review. — View Citation
Cooper LB, Lippmann SJ, Greiner MA, Sharma A, Kelly JP, Fonarow GC, Yancy CW, Heidenreich PA, Hernandez AF. Use of Mineralocorticoid Receptor Antagonists in Patients With Heart Failure and Comorbid Diabetes Mellitus or Chronic Kidney Disease. J Am Heart Assoc. 2017 Dec 23;6(12). pii: e006540. doi: 10.1161/JAHA.117.006540. — View Citation
Espinel E, Agraz I, Ibernon M, Ramos N, Fort J, Serón D. Renal Biopsy in Type 2 Diabetic Patients. J Clin Med. 2015 May 18;4(5):998-1009. doi: 10.3390/jcm4050998. Review. — View Citation
Galle J. Reduction of proteinuria with angiotensin receptor blockers. Nat Clin Pract Cardiovasc Med. 2008 Jul;5 Suppl 1:S36-43. doi: 10.1038/ncpcardio0806. Review. — View Citation
Jalal S, Sofi FA, Abass SM, Alai MS, Bhat MA, Rather HA, Lone NA, Siddiqi MA. Effect of amlodipine and lisinopril on microalbuminuria in patients with essential hypertension: A prospective study. Indian J Nephrol. 2010 Jan;20(1):15-20. doi: 10.4103/0971-4065.62090. — View Citation
Satirapoj B, Adler SG. Prevalence and Management of Diabetic Nephropathy in Western Countries. Kidney Dis (Basel). 2015 May;1(1):61-70. doi: 10.1159/000382028. Epub 2015 May 1. Review. — View Citation
Zelmanovitz T, Gerchman F, Balthazar AP, Thomazelli FC, Matos JD, Canani LH. Diabetic nephropathy. Diabetol Metab Syndr. 2009 Sep 21;1(1):10. doi: 10.1186/1758-5996-1-10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Urinary albumin/creatinin ratio (UACR) | Percentage change in albumin/creatinin ratio compared with the baseline value | 24 weeks | |
Secondary | Blood pressure | change in blood pressure level | 24 weeks | |
Secondary | estimated Glomerular Filtration Rate (e GFR) | change in estimated Glomerular Filtration Rate (e GFR) | 24 weeks | |
Secondary | Serum K | change in serum K level | 24 weeks |
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