Clinical trial NCT01003392: Influence of Coffee on the Health and on the Heart of Normal, Diabetics e Coronary Artery Disease Patients
Official title: Study of Coffee and Its Influence on the Heart in Normal People, Those With Coronary Artery Disease and Diabetics.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
Coffee
Heart system
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Feculdade de Medicina da Universidade de Sao Paulo - Brasil
First posted: 2009-10-28
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Group of normal patients, group of patients with diagnosed coronary artery disease and group of diabetic patients.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Verify the relationship between coffee ingestion and cardiovascular morbidity and mortality
timeFrame: 10 years of follow-up
Secondary outcomes:
measure: Relationship between coffee ingestion and cardiovascular risk factors
timeFrame: 10 years
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Heart Institute (InCor), Univ. of Sao Paulo Medical School
Study officials:
affiliation: Heart Institute
name: Luiz A Machado Cesar, PhD, MD.
role: STUDY_CHAIR
References: