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

Coronary Artery Disease Clinical Trial

— Coffee&Heart  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01003392
• Other study ID #: SDC2500/04/120
• Secondary ID: CAPPesq-879/04
• Status: Recruiting
• Phase: N/A
• First received: October 26, 2009
• Last updated: January 6, 2014
• Start date: March 2008
• Est. completion date: December 2014

Study information

• Verified date: January 2014
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Brazil	Heart Institute (InCor), Univ. of Sao Paulo Medical School	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Feculdade de Medicina da Universidade de Sao Paulo - Brasil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Verify the relationship between coffee ingestion and cardiovascular morbidity and mortality		10 years of follow-up	No
Secondary	Relationship between coffee ingestion and cardiovascular risk factors		10 years	No