Influence of Coffee on the Health and on the Heart of Nor... | NCT01003392

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

NCT01003392

Sponsor

University of Sao Paulo

Status

Unknown status

Last Update Posted

Jan 7, 2014Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

Not provided

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CAPPesq-879/04	Other Identifier	CAPPesq

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Dec 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Oct 26, 2009

First Submission Date that Met QC Criteria

Oct 27, 2009

First Posted Date

Oct 28, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 6, 2014

Last Update Posted Date

Jan 7, 2014Estimated

Name	Class
Feculdade de Medicina da Universidade de Sao Paulo - Brasil	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Normal		Normal volunteers, with no diagnosed chronic disease.
Coronary artery disease		Group of patients with diagnosed coronary artery disease.
Diabetes		Diabetic patients.

Interventions

Not provided

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

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Normal Volunteers:

Healthy volunteer.
Age between 20 and 80 years.
No addict to drugs.
Absence of chronicle diseases.
No alcohol abuse.
No smoker.

Coronary artery disease:

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

Diabetes:

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

Exclusion Criteria:

Normal Volunteers:

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

Coronary artery disease:

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

Diabetes:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Type	Date	Date Unknown
Release	Sep 9, 2021
Reset	Oct 6, 2021

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases