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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01130727
• Other study ID #: GTCOCOA-01
• Status: Completed
• Phase: N/A
• First received: May 18, 2010
• Last updated: April 17, 2012
• Start date: May 2010
• Est. completion date: February 2012

Study information

• Verified date: April 2012
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Arterial Hypertension
• Diabetes Mellitus
• Diabetic Nephropathies
• Diabetic Nephropathy
• Hypertension
• Kidney Diseases

Intervention

Other:
• green tea extract
1.21g of green tea extract (965 mg of flavonols)
• cocoa extract rich in polyphenols
2.14 g of cocoa extract rich in polyphenols equivalent to 965 mg of polyphenols
• placebo
placebo
• low polyphenol cocoa extract
placebo

Locations

Country	Name	City	State
Brazil	University Hospital	Campinas	Sao Paulo

Sponsors (3)

Lead Sponsor	Collaborator
University of Campinas, Brazil	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	flow-mediated dilation (FMD)		up to 4 hours	No
Secondary	arterial blood pressure and cardiac rate		up to 4 hours	No
Secondary	plasma levels of flavonols		up to 4 hours	No