Ramadan Fasting Effects in Patients With Cardiovascular Risk Factors

June 17, 2016 updated by: Pr. Semir Nouira, University of Monastir
Ramadan Fasting has multiple effects on the variation of hematological and biochemical parameters.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective observational study, including patients with cardiovascular risk factors and doing the fast of Ramadan with assessment before, during and after the month of Ramadan.

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
    • Non-US/Canada
      • Monastir, Non-US/Canada, Tunisia, 5000
        • Emergency Departement

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Stable patients with cardiovascular risk factors who fast during Ramadan

Description

Inclusion Criteria:

  • Patients with cardiovascular risk factors in stable conditions
  • Ramadan fasting

Exclusion Criteria:

  • Impossibility, contraindication or interruption of fasting

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with cardiovascular risk factors who fast Ramadan
Stable clinical and biochemical parameters before Ramadan fasting
Biological: biochemical parameters

patients will be collected for analysis of blood standard examinations such as blood glucose, electrolytes (potassium, sodium, magnesium calcium), renal function and also the blood count, platelet aggregation.

All these tests should be practice before, during and after Ramadan fasting for comparison.

Other Names:
  • hematological parameters assay
  • verify now assay

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
all cause clinical complications
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
evidence of acute coronary complications
Time Frame: 5 years
5 years

Other Outcome Measures

Outcome Measure
Time Frame
clopidogrel and aspirin related complications
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Monastir

Investigators

  • Principal Investigator: Semir Nouira, Pr., University Hospital Of Monastir Tunisia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

July 24, 2014

First Submitted That Met QC Criteria

March 24, 2016

First Posted (Estimate)

March 25, 2016

Study Record Updates

Last Update Posted (Estimate)

June 20, 2016

Last Update Submitted That Met QC Criteria

June 17, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GR2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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