Ramadan Fasting Effects in Patients With Cardiovascular Risk Factors

Sponsor

University of Monastir (Other)

Overall Status

Completed

CT.gov ID

NCT02720133

Collaborator

(none)

500

Enrollment

Location

Duration (Months)

19.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Ramadan Fasting has multiple effects on the variation of hematological and biochemical parameters.

Condition or Disease	Intervention/Treatment	Phase
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

Study Type:

Observational [Patient Registry]

Actual Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Ramadan Fasting Effects in Patients With Cardiovascular Risk Factors

Study Start Date :

Jul 1, 2013

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	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

Arm

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

Primary Outcome Measures

all cause clinical complications [5 years]

Secondary Outcome Measures

evidence of acute coronary complications [5 years]

Other Outcome Measures

clopidogrel and aspirin related complications [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients with cardiovascular risk factors in stable conditions
Ramadan fasting

Exclusion Criteria:

Impossibility, contraindication or interruption of fasting

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emergency Departement	Monastir	Non-US/Canada	Tunisia	5000

Sponsors and Collaborators

University of Monastir

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

The effects of ramadan fasting and physical activity on glycemic control, lipid metabolism, and the effects clopidogrel and aspirin activityameters.

Publications

None provided.

Responsible Party:

Pr. Semir Nouira, Head of departement, University of Monastir

ClinicalTrials.gov Identifier:

NCT02720133

Other Study ID Numbers:

First Posted:

Mar 25, 2016

Last Update Posted:

Jun 20, 2016

Last Verified:

Jun 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Keywords provided by Pr. Semir Nouira, Head of departement, University of Monastir

ramadan fasting

variation of biochemical parameters

variation of hematological parameters

verify now assay

Study Results

No Results Posted as of Jun 20, 2016