Diabetes MellitusNCT01130727
The Effect of Green Tea or Cocoa Extracts in Endothelial Dysfunction in Patients With Diabetes Mellitus
A study testing green tea extract, cocoa extract rich in polyphenols and low polyphenol cocoa extract in people with Diabetes Mellitus and Diabetic Nephropathy, run by University of Campinas, Brazil at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Diabetic Nephropathy, Arterial Hypertension
- What is being tested?
- green tea extract, cocoa extract rich in polyphenols and low polyphenol cocoa extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteBrazil
- Study dates
- May 2010to Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 or type 2 diabetes mellitus
- Diabetic nephropathy
- Hypertension
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- green tea extract, cocoa extract rich in polyphenols, placebo, low polyphenol cocoa extract
- Keywords
- diabetes mellitus, diabetic nephropathy, hypertension, green tea, cocoa, polyphenol, nitric oxide
- Medical subject headings
- Diabetes Mellitus, Diabetic Nephropathies, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
green tea extractOther
Also called Green tea extract, sunphenon 90DCF-T, Tayo, CO., LTD
1.21g of green tea extract (965 mg of flavonols)
cocoa extract rich in polyphenolsOther
Also called Acticoa cocoa extract NCE-PO803-W41, Barry Callebaut, Belgium
2.14 g of cocoa extract rich in polyphenols equivalent to 965 mg of polyphenols
placeboOther
placebo
low polyphenol cocoa extractOther
Also called placebo cocoa extract, Barry Callebaut, Belgium
placebo
| Study group | Role | What they receive |
|---|---|---|
| green tea extract | Active comparator | Not described Receives: Other: green tea extract |
| Cocoa extract rich in polyphenols | Active comparator | Not described Receives: Other: cocoa extract rich in polyphenols |
| placebo | Placebo comparator | Not described Receives: Other: placebo |
| cocoa extract with low polyphenol | Placebo comparator | Not described Receives: Other: low polyphenol cocoa extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
flow-mediated dilation (FMD)
Measured: up to 4 hours
Secondary outcomes (2)
arterial blood pressure and cardiac rate
Measured: up to 4 hours
plasma levels of flavonols
Measured: up to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2010 (estimated)
- Study startMay 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Jose Butori Lopes de Faria, University of Campinas, Brazil
- Investigators
- Jose b Lopes de Faria, M.D., Principal investigator, Universidade Estadual de Campinas, Unicamp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01130727
- Sponsor's protocol ID
- GTCOCOA-01
- Status last verified
- Apr 2012
- First submitted
- 18 May 2010
- Last updated
- 19 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01130727
- Acronym / sponsor ID
- GTCOCOA-01
- Keywords
- diabetes mellitus, diabetic nephropathy, hypertension, green tea, cocoa, polyphenol, nitric oxide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- May 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 26 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 1 or type 2 diabetes mellitus
- Diabetic nephropathy
- Hypertension
Key exclusion criteria (8 listed)
- GFR < 30 ml/min/1.73m2
- Serum K > 5.5 mEq/L
- Age < 18 y
- Pregnancy
- Breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| green tea extractAlso: Green tea extract, sunphenon 90DCF-T, Tayo, CO., LTD1.21g of green tea extract (965 mg of flavonols) | Other | green tea extract |
| cocoa extract rich in polyphenolsAlso: Acticoa cocoa extract NCE-PO803-W41, Barry Callebaut, Belgium2.14 g of cocoa extract rich in polyphenols equivalent to 965 mg of polyphenols | Other | Cocoa extract rich in polyphenols |
| placeboplacebo | Other | placebo |
| low polyphenol cocoa extractAlso: placebo cocoa extract, Barry Callebaut, Belgiumplacebo | Other | cocoa extract with low polyphenol |
Primary outcome
flow-mediated dilation (FMD)
Time frame: up to 4 hours
2 secondary outcomes
arterial blood pressure and cardiac rate
Time frame: up to 4 hours
plasma levels of flavonols
Time frame: up to 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose b Lopes de Faria, M.D. principal investigator
Universidade Estadual de Campinas, Unicamp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing green tea extract, cocoa extract rich in polyphenols and low polyphenol cocoa extract in people with Diabetes Mellitus and Diabetic Nephropathy, run by University of Campinas, Brazil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
flow-mediated dilation (FMD) (time frame: up to 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2012.