Effect of Green Tea (Epigallocatechin Gallate) on Albuminuria in Patients With Diabetic Nephropathy.

University of Campinas, Brazil

Status and phase

Completed

Phase 2

Conditions

Diabetic Nephropathy

Hypertension

Treatments

Drug: Green tea extract

Study type

Interventional

Funder types

Other

Identifiers

NCT01923597

Fapesp-2013

Details and patient eligibility

About

The purpose of this study is to determine the safety and effect of green tea (epigallocatechin gallate) in albuminuria in diabetic patients and nephropathy.

Full description

Clinical, prospective, randomized, double-blind, placebo-controlled, with analysis by intention to treat.

50 individuals will be selected with a diagnosis of diabetes / hypertension and has been followed in Diabetic Nephropathy Clinic of the Faculty of Medical Sciences, University of Campinas (UNICAMP). Participants are divided into 02 groups: 1) 25 patients treated with maximum dose of ACE-I and / or angiotensin II receptor blocker (ARBs) + Placebo (absence of epigallocatechin gallate) and 2) treated 25 patients with maximum dose of ACE-I and / or ARBs + green tea (epigallocatechin gallate).

The patients will receive four capsules Polyphenol E - epigallocatechin gallate (Polyphenon Pharma, NY) per day, corresponding to 800 mg of epigallocatechin gallate (EGCG), or placebo (no epigallocatechin gallate) for 3 months. Patients will not be aware of the treatment they are receiving. The subjects will be allocated for the treatment or placebo, stratified by sex. To avoid the influence of researchers, the randomization list will be generated and maintained by trained personnel in a different location from the study. Before treatment and immediately after 3 months of treatment will be obtained in the primary outcome measures (albuminuria) and secondary (plasma metabolites of flavonoids, level of urinary F2-isoprostane and 8-hydroxydeoxyguanosine). In these same times will be obtained: blood biochemistry (glucose, glycosylated hemoglobin, urea, creatinine, sodium, potassium, blood count, calcium, phosphorus, cholesterol, LDL, HDL, triglycerides, uric acid), 3 samples of first morning urine to determine albuminuria, glomerular filtration rate (GFR), blood pressure measurement of 24 h, physical examination, weight, blood pressure and heart rate. Adherence to the study will be evaluated by weekly phone and the expected increase in plasma of flavonoids using the green tea (epigallocatechin gallate). The antihypertensive drug may be adjusted to obtain the desired pressure (<130/80 mmHg).

Enrollment

50 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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