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

University of Campinas, Brazil

Status: Completed

Conditions: Diabetic Nephropathy; Arterial Hypertension; Diabetes Mellitus

Treatments: Other: green tea extract; Other: low polyphenol cocoa extract; Other: placebo; Other: cocoa extract rich in polyphenols

Study type: Interventional

Funder types: Other

Identifiers

NCT01130727

GTCOCOA-01

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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51 participants in 4 patient groups, including a placebo group

green tea extract

Active Comparator group

Treatment:

Other: green tea extract

Cocoa extract rich in polyphenols

Active Comparator group

Treatment:

Other: cocoa extract rich in polyphenols

placebo

Placebo Comparator group

Treatment:

Other: placebo

cocoa extract with low polyphenol

Placebo Comparator group

Treatment:

Other: low polyphenol cocoa extract