Influence of Coffee on the Health and on the Heart of Normal, Diabetics e Coronary Artery Disease Patients (Coffee&Heart)

January 6, 2014 updated by: Luiz Antonio M. Cesar, University of Sao Paulo

Study of Coffee and Its Influence on the Heart in Normal People, Those With Coronary Artery Disease and Diabetics.

Coffee is a worldwide drink, been part of any culture. There are some concerns about effects of coffee on the health. Recently, epidemiological studies have shown benefits of coffee drinking to diabetics and also to prevent diabetes in populations. We aim to understand some effects of coffee and not only caffeine over vascular system, in special coronary artery disease patients, diabetics end normal people.

Study Overview

Status

Unknown

Conditions

Detailed Description

Patients will have a wash-out period (21 days) with no coffee or other caffeine-drinks. Then they will be submitted to treadmill test, MAPA, Holter-ECG and vascular reactivity study, biochemical and inflammatory plasma dosages, as basal. Then they will start a period of coffee drinking over 4 weeks; and all exams will be repeated. We will study two types of coffee, arabica and robusta; with two types of toasted beans(regular and soft). Also regular and decaffeinated coffee. A total of 300 (100 normal people, 100 diabetics, 100 coronary disease) individuals will be tested.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05403000
        • Recruiting
        • Heart Institute (InCor), Univ. of Sao Paulo Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Group of normal patients, group of patients with diagnosed coronary artery disease and group of diabetic patients.

Description

Inclusion Criteria:

Normal Volunteers:

  1. Healthy volunteer.
  2. Age between 20 and 80 years.
  3. No addict to drugs.
  4. Absence of chronicle diseases.
  5. No alcohol abuse.
  6. No smoker.

Coronary artery disease:

  1. Presence of coronary artery disease, by coronary angiography
  2. Stable angina, class 1-3 of CCS.
  3. Age between 20 and 80 years.
  4. Treadmill effort test with ischemia.
  5. No alcohol abuse.
  6. No smoker.

Diabetes:

  1. Presence of type II Diabetes on oral treatment.
  2. Age between 20 and 80 years.
  3. Absence of chronicle diseases, except diabetes.
  4. No alcohol abuse.
  5. No smoker.

Exclusion Criteria:

Normal Volunteers:

  1. Any blood test with twice or more the upper limit range.
  2. Presence of enlarged QRS.

Coronary artery disease:

  1. Any blood test with twice or more the upper limit range even with treatment.
  2. Presence of enlarged QRS.
  3. Ventricular dysfunction (EF < 45%).

Diabetes:

  1. Blood glucose greater than 160 mg/dL.
  2. Others blood tests with twice or more the upper limit range even with treatment.
  3. Presence of enlarged QRS.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Normal
Normal volunteers, with no diagnosed chronic disease.
Coronary artery disease
Group of patients with diagnosed coronary artery disease.
Diabetes
Diabetic patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Verify the relationship between coffee ingestion and cardiovascular morbidity and mortality
Time Frame: 10 years of follow-up
10 years of follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Relationship between coffee ingestion and cardiovascular risk factors
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Feculdade de Medicina da Universidade de Sao Paulo - Brasil

Investigators

  • Study Chair: Luiz A Machado Cesar, PhD, MD., Heart Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

October 26, 2009

First Submitted That Met QC Criteria

October 27, 2009

First Posted (Estimate)

October 28, 2009

Study Record Updates

Last Update Posted (Estimate)

January 7, 2014

Last Update Submitted That Met QC Criteria

January 6, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDC2500/04/120
  • CAPPesq-879/04 (Other Identifier: CAPPesq)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe