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

This study has been completed.
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Jose Butori Lopes de Faria, University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01130727
First received: May 18, 2010
Last updated: April 17, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Diabetic Nephropathy
Arterial Hypertension
 Other: green tea extract
Other: cocoa extract rich in polyphenols
Other: placebo
Other: low polyphenol cocoa extract

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:
  • flow-mediated dilation (FMD) [ Time Frame: up to 4 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • arterial blood pressure and cardiac rate [ Time Frame: up to 4 hours ] [ Designated as safety issue: No ]
  • plasma levels of flavonols [ Time Frame: up to 4 hours ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: May 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: green tea extract Other: green tea extract
1.21g of green tea extract (965 mg of flavonols)
Other Name: Green tea extract, sunphenon 90DCF-T, Tayo, CO., LTD
Active Comparator: Cocoa extract rich in polyphenols Other: cocoa extract rich in polyphenols
2.14 g of cocoa extract rich in polyphenols equivalent to 965 mg of polyphenols
Other Name: Acticoa cocoa extract NCE-PO803-W41, Barry Callebaut, Belgium
Placebo Comparator: placebo Other: placebo
placebo
Other Name: placebo
Placebo Comparator: cocoa extract with low polyphenol Other: low polyphenol cocoa extract
placebo
Other Name: placebo cocoa extract, Barry Callebaut, Belgium

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01130727

Locations
Brazil
University Hospital
Campinas, Sao Paulo, Brazil, 13084-971
Sponsors and Collaborators
University of Campinas, Brazil
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Principal Investigator: Jose b Lopes de Faria, M.D. Universidade Estadual de Campinas Unicamp
  More Information

No publications provided

Responsible Party: Jose Butori Lopes de Faria, Professor, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT01130727     History of Changes
Other Study ID Numbers: GTCOCOA-01
Study First Received: May 18, 2010
Last Updated: April 17, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Campinas, Brazil:
diabetes mellitus
diabetic nephropathy
hypertension
green tea
 cocoa
polyphenol
nitric oxide

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetic Nephropathies
Hypertension
Kidney Diseases
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Urologic Diseases
Diabetes Complications
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013