Effects of Ramadan Fasting on Endothelial Function

• Conditions: Endothelial Dysfunction; Fasting
• Interventions: Diagnostic Test: Reactive hyperemia-peripheral arterial tonometry Index (RHI )

• Registration Number: NCT05331443
• Lead Sponsor: University of Monastir

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 .

Study Timeline

• Study Start: 2022-03-15
• Study First Submitted: 2022-04-11
• Study First Submitted QC: 2022-04-11
• Study First Posted: 2022-04-15
• Primary Completion: 2023-05-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18
• Study Completion: 2024-07-15

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
participents who has the intention to fast Ramadan	Reactive hyperemia-peripheral arterial tonometry Index (RHI )	subjects with at least two cardiovascular risk factors according to Framingham classification or with out any risk .

Primary Outcome Measures

Name	Time	Method
Change in Reactive Hyperemia Index (RHI)	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.

Trial Locations

Locations (1)

University hospital Fattouma Bourguiba; 🇹🇳 Monastir, Tunisia