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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-03-31

Brief Summary

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

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Detailed Description

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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).

Conditions

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Diabetic Nephropathy Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Green tea extract

Patients will receive four capsules ( one capsula = 200mg of epigallocatechin gallate) of green tea extract per day for 3 months.

Group Type ACTIVE_COMPARATOR

Green tea extract

Intervention Type DRUG

200mg/capsule Administered orally 4 capsules per day For 3 months

Placebo (celulose)

Patients will receive four capsules of placebo (celulose) daily for 3 months.

Group Type PLACEBO_COMPARATOR

Green tea extract

Intervention Type DRUG

200mg/capsule Administered orally 4 capsules per day For 3 months

Interventions

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Green tea extract

200mg/capsule Administered orally 4 capsules per day For 3 months

Intervention Type DRUG

Other Intervention Names

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Epigallocatechin gallate Polyphenol e

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No