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Completed

NCT Number: NCT01130727

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

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.

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Key information

Conditions

Diabetes Mellitus Arterial Hypertension Cardiovascular Diseases Diabetes Complications Diabetic Nephropathies Diabetic Nephropathy Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hypertension Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Campinas, São Paulo, 13084-971, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

green tea extract

Other

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

Other names: Green tea extract, sunphenon 90DCF-T, Tayo, CO., LTD

cocoa extract rich in polyphenols

Other

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

Other names: Acticoa cocoa extract NCE-PO803-W41, Barry Callebaut, Belgium

Placebo

Other

placebo

low polyphenol cocoa extract

Other

placebo

Other names: placebo cocoa extract, Barry Callebaut, Belgium

Primary outcomes

  1. flow-mediated dilation (FMD)

    Time frame: up to 4 hours

Secondary outcomes

  1. arterial blood pressure and cardiac rate

    Time frame: up to 4 hours

  2. plasma levels of flavonols

    Time frame: up to 4 hours

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Randomized Clinical Trial, Placebo Controlled, With Parallel Groups to Investigate Whether Green Tea or Cocoa Extracts Improves Endothelial Dysfunction in Patients With Diabetes Mellitus and Nephropathy and Hypertension

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 26, 2010
Registry last updated
Apr 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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