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Clinical Trials/NCT05331443
NCT05331443
Enrolling By Invitation
Not Applicable

Effects of Ramadan Fasting on Endothelial Function

University of Monastir1 site in 1 country250 target enrollmentMarch 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fasting
Sponsor
University of Monastir
Enrollment
250
Locations
1
Primary Endpoint
Change in Reactive Hyperemia Index (RHI)
Status
Enrolling By Invitation
Last Updated
2 years ago

Overview

Brief Summary

Include participants who intend to practice Ramadan fasting and accept to complete the three part of the study .

Detailed Description

All volunteers and stable patients that intend to fast ramadan. Each participant is examined during three separate visits. 1. The week before Ramadan (Pre-R). 2. the last week of Ramadan (R). 3. the last week of the month following Ramadan (Post-R). Participants that miss one appointement or more are exluded from the study. Patient recrutement is conducted in primary care centers of the state of Monastir, out-patients clinic (Cardiology, Endocrinology) at the emergency department of Fattouma Bourguiba university hospital after a clarified written consent. All patients benifit of an endothelial peripheral arterial tonometry (Endo-PAT) test .

Registry
clinicaltrials.gov
Start Date
March 15, 2022
End Date
July 15, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pr. Semir Nouira

Professor

University of Monastir

Eligibility Criteria

Inclusion Criteria

  • Adult patient intending to fast Ramadan.

Exclusion Criteria

  • Age \< 18 years old
  • Hemodynamic instability.
  • Myocardial infarction requiring urgent revascularization.
  • Parkinsonism: tremor problem.
  • Refusal, communication problem.

Outcomes

Primary Outcomes

Change in Reactive Hyperemia Index (RHI)

Time Frame: the day of inclusion , 10 last day of Ramadan , 1 month after Ramadan

RHI is calculated for each participant in the day of iclusion , then it is recalculated in the two others visits.

Study Sites (1)

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