Hypertension Clinical Trial
Official title:
A Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Effect of Green Tea on Albuminuria in Patients With Diabetic Nephropathy and Use of Maximum Dose of ACE-I and / or Angiotensin II Receptor Blocker.
The purpose of this study is to determine the safety and effect of green tea (epigallocatechin gallate) in albuminuria in diabetic patients and nephropathy.
Status | Completed |
Enrollment | 50 |
Est. completion date | March 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - 18 years or more - prior diagnosis of diabetes mellitus (DM) - persistent micro-or macroalbuminuria (urinary albumin excretion> 30 mg / g creatinine (AUC) in 3 consecutive measurements on different days) - glycated hemoglobin <10% - maximum dose of ACE-I and / or ARBs. Exclusion Criteria: - diagnosis of autoimmune diseases, HIV, hepatitis, cancer, inflammatory disease - pregnant or lactating patients - glomerular filtration rate (GFR) <30 ml/min/1, 73m2 (estimated by the MDRD and the Cockcroft-Gault formula) - presence of kidney disease unrelated to diabetes - chronic urinary tract infection - diagnosis of congestive heart failure (CHF) New York Heart Association (NYHA) class III or IV - recent history (<6 months) unstable angina, myocardial infarction, stroke, coronary intervention - history of alcohol and / or drugs - mental incapacity to understand the informed consent - intolerance to green tea |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Unicamp | Campinas | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Campinas, Brazil |
Brazil,
Borges CM, Papadimitriou A, Duarte DA, Lopes de Faria JM, Lopes de Faria JB. The use of green tea polyphenols for treating residual albuminuria in diabetic nephropathy: A double-blind randomised clinical trial. Sci Rep. 2016 Jun 20;6:28282. doi: 10.1038/s — View Citation
Faria AM, Papadimitriou A, Silva KC, Lopes de Faria JM, Lopes de Faria JB. Uncoupling endothelial nitric oxide synthase is ameliorated by green tea in experimental diabetes by re-establishing tetrahydrobiopterin levels. Diabetes. 2012 Jul;61(7):1838-47. doi: 10.2337/db11-1241. Epub 2012 May 14. — View Citation
Ribaldo PD, Souza DS, Biswas SK, Block K, Lopes de Faria JM, Lopes de Faria JB. Green tea (Camellia sinensis) attenuates nephropathy by downregulating Nox4 NADPH oxidase in diabetic spontaneously hypertensive rats. J Nutr. 2009 Jan;139(1):96-100. doi: 10.3945/jn.108.095018. Epub 2008 Dec 3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Effect of Green Tea (epigallocatechin gallate) in the glomerular filtration rate in patients with diabetic nephropathy. | Estimated by Modification of Diet in Renal Disease (MDRD) formula. | After 3 months of treatment | Yes |
Primary | Effect of green tea (epigallocatechin gallate) in albuminuria in diabetic patients and nephropathy. | Mean of 3 urinary albumin to creatinine ratio. | After 3 months of treatment | Yes |
Secondary | Effect of green tea (epigallocatechin gallate) on oxidative stress in patients with diabetic nephropathy. | Urinary levels of F2-isoprostane and 8-hydroxydeoxyguanosine | After 3 months of treatment | No |
Secondary | Effect of green tea (epigallocatechin gallate) on blood glucose control in patients with diabetic nephropathy. | Glycemia and glycated hemoglobin | After 3 months of tretatment | Yes |
Secondary | Effect of green tea (epigallocatechin gallate) on blood pressure in patients with diabetic nephropathy. | 24 h blood pressure monitoring | After 3 months of treatment | Yes |
Secondary | Effect of green tea (epigallocatechin gallate) on plasma lipids in patients with diabetic nephropathy. | Plasma levels of HDL. | After 3 months of treatment | Yes |
Secondary | Effect of green tea (epigallocatechin gallate) on plasma metabolites of flavonoids in patients with diabetic nephropathy. | Plasma levels of epigallocatechin gallate and epicatechin. | After 3 months of treatment | Yes |
Secondary | Effect of green tea (epigallocatechin gallate) on plasma lipids in patients with diabetic nephropathy. | Plasma levels of LDL. | After 3 months of treatment | Yes |
Secondary | Effect of green tea (epigallocatechin gallate) on plasma lipids in patients with diabetic nephropathy. | Plasma levels of triglycerides. | After 3 months of treatment | Yes |
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