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.
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).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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