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

• Conditions: Coronary Artery Disease

• Registration Number: NCT01003392
• Lead Sponsor: University of Sao Paulo

Brief 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.

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 Timeline

• Study Start: 2008-03
• Study First Submitted: 2009-10-26
• Study First Submitted QC: 2009-10-27
• Study First Posted: 2009-10-28
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-06
• Last Update Posted: 2014-01-07
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Verify the relationship between coffee ingestion and cardiovascular morbidity and mortality	10 years of follow-up

Secondary Outcome Measures

Name	Time	Method
Relationship between coffee ingestion and cardiovascular risk factors	10 years

Trial Locations

Locations (1)

Heart Institute (InCor), Univ. of Sao Paulo Medical School; 🇧🇷 Sao Paulo, Brazil