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Ramadan Fasting Effects in Patients With Cardiovascular Risk Factors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02720133
Recruitment Status : Completed
First Posted : March 25, 2016
Last Update Posted : June 20, 2016
Sponsor:
Information provided by (Responsible Party):
Pr. Semir Nouira, University of Monastir

Study Description
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Brief Summary:
Ramadan Fasting has multiple effects on the variation of hematological and biochemical parameters.

Condition or disease Intervention/treatment
Cardiovascular Risk Factors Fasting Biological: biochemical parameters

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 Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Ramadan Fasting Effects in Patients With Cardiovascular Risk Factors
Study Start Date : July 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. all cause clinical complications [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. evidence of acute coronary complications [ Time Frame: 5 years ]

Other Outcome Measures:
  1. clopidogrel and aspirin related complications [ Time Frame: 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Stable patients with cardiovascular risk factors who fast during Ramadan
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Impossibility, contraindication or interruption of fasting
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02720133


Locations
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Tunisia
Emergency Departement
Monastir, Non-US/Canada, Tunisia, 5000
Sponsors and Collaborators
University of Monastir
Investigators
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Principal Investigator: Semir Nouira, Pr. University Hospital Of Monastir Tunisia
More Information
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Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pr. Semir Nouira, Head of departement, University of Monastir
ClinicalTrials.gov Identifier: NCT02720133    
Other Study ID Numbers: GR2
First Posted: March 25, 2016    Key Record Dates
Last Update Posted: June 20, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Pr. Semir Nouira, University of Monastir:
ramadan fasting
variation of biochemical parameters
variation of hematological parameters
verify now assay