NCT01130727

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 26, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

April 19, 2012

Status Verified

April 1, 2012

Enrollment Period

1.8 years

First QC Date

May 18, 2010

Last Update Submit

April 17, 2012

Conditions

Diabetes MellitusDiabetic NephropathyArterial Hypertension

Keywords

diabetes mellitusdiabetic nephropathyhypertensiongreen teacocoapolyphenolnitric oxide

Outcome Measures

Primary Outcomes (1)

  • flow-mediated dilation (FMD)

    up to 4 hours

Secondary Outcomes (2)

  • arterial blood pressure and cardiac rate

    up to 4 hours

  • plasma levels of flavonols

    up to 4 hours

Study Arms (4)

green tea extract

ACTIVE COMPARATOR
Other: green tea extract

Cocoa extract rich in polyphenols

ACTIVE COMPARATOR
Other: cocoa extract rich in polyphenols

placebo

PLACEBO COMPARATOR
Other: placebo

cocoa extract with low polyphenol

PLACEBO COMPARATOR
Other: low polyphenol cocoa extract

Interventions

green tea extractOTHER

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

Also known as: Green tea extract, sunphenon 90DCF-T, Tayo, CO., LTD
green tea extract
cocoa extract rich in polyphenolsOTHER

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

Also known as: Acticoa cocoa extract NCE-PO803-W41, Barry Callebaut, Belgium
Cocoa extract rich in polyphenols
placeboOTHER

placebo

placebo
low polyphenol cocoa extractOTHER

placebo

Also known as: placebo cocoa extract, Barry Callebaut, Belgium
cocoa extract with low polyphenol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 or type 2 diabetes mellitus
  • Diabetic nephropathy
  • Hypertension

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Campinas, São Paulo, 13084-971, Brazil

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetic NephropathiesHypertension

Interventions

TeaLong-Term Synaptic DepressionPolyphenols

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesNeuronal PlasticityNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Jose b Lopes de Faria, M.D.

    Universidade Estadual de Campinas, Unicamp

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 18, 2010

First Posted

May 26, 2010

Study Start

May 1, 2010

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

April 19, 2012

Record last verified: 2012-04

Locations

BR(1)