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

NCT ID: NCT01003392

Last Updated: 2014-01-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2014-12-31

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.

Conditions

Coronary Artery Disease

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

Normal

Normal volunteers, with no diagnosed chronic disease.

No interventions assigned to this group

Coronary artery disease

Group of patients with diagnosed coronary artery disease.

No interventions assigned to this group

Diabetes

Diabetic patients.

No interventions assigned to this group

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Feculdade de Medicina da Universidade de Sao Paulo - Brasil

OTHER

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Luiz Antonio M. Cesar

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luiz A Machado Cesar, PhD, MD.

Role: STUDY_CHAIR

Heart Institute

Locations

Heart Institute (InCor), Univ. of Sao Paulo Medical School

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Facility Contacts

Luiz A Machado Cesar, Phd, MD

Role: primary

luiz.cesar@incor.usp.br

551130695387

Bruno M Mioto, MD

Role: backup

brunomioto@gmail.com

551130695437

Other Identifiers

CAPPesq-879/04

Identifier Type: OTHER

Identifier Source: secondary_id

SDC2500/04/120

Identifier Type: -

Identifier Source: org_study_id