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

Not Applicable

Completed

• Conditions: Diabetes Mellitus; Diabetic Nephropathy; Arterial Hypertension
• Interventions: Other: green tea extract; Other: cocoa extract rich in polyphenols; Other: placebo; Other: low polyphenol cocoa extract

• Registration Number: NCT01130727
• Lead Sponsor: University of Campinas, Brazil

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-18
• Study First Submitted QC: 2010-05-24
• Study First Posted: 2010-05-26
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-17
• Last Update Posted: 2012-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
green tea extract	green tea extract	-
Cocoa extract rich in polyphenols	cocoa extract rich in polyphenols	-
placebo	placebo	-
cocoa extract with low polyphenol	low polyphenol cocoa extract	-

Primary Outcome Measures

Name	Time	Method
flow-mediated dilation (FMD)	up to 4 hours

Secondary Outcome Measures

Name	Time	Method
arterial blood pressure and cardiac rate	up to 4 hours
plasma levels of flavonols	up to 4 hours

Trial Locations

Locations (1)

University Hospital; 🇧🇷 Campinas, Sao Paulo, Brazil