The Effect of Green Tea or Cocoa Extracts in Endothelial Dysfunction in Patients With Diabetes Mellitus

University of Campinas, Brazil51 enrolled

Overview

The purpose of this study is to determine whether green tea or cocoa extracts are effective in improve endothelial dysfunction in patients with diabetes mellitus and nephropathy and arterial hypertension.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Diabetes Mellitus Diabetic Nephropathy Arterial Hypertension

Interventions

green tea extractOTHER

1.21g of green tea extract (965 mg of flavonols)

cocoa extract rich in polyphenolsOTHER

2.14 g of cocoa extract rich in polyphenols equivalent to 965 mg of polyphenols

placeboOTHER

placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 1 or type 2 diabetes mellitus * Diabetic nephropathy * Hypertension Exclusion Criteria: * GFR \< 30 ml/min/1.73m2 * Serum K \> 5.5 mEq/L * Age \< 18 y * Pregnancy * Breast feeding * Cocoa or green tea intolerance * Alcohol and drugs abuse * Incapacity to understand the information related to the study

Locations (1)

University Hospital

Campinas, São Paulo, Brazil

Outcomes

Primary Outcomes

flow-mediated dilation (FMD)

Time frame: up to 4 hours

Secondary Outcomes

arterial blood pressure and cardiac rate

Time frame: up to 4 hours

plasma levels of flavonols

Time frame: up to 4 hours

Data from ClinicalTrials.gov

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