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NCT05331443 Clinical Trial

Effects of Ramadan Fasting on Endothelial Function

Endothelial Dysfunction Clinical Trial

Official title:
Effects of Ramadan Fasting on Endothelial Function

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05331443
Other study ID # RHIFasting
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date March 15, 2022
Est. completion date July 15, 2024

Study information
Verified date November 2023
Source University of Monastir
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

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 .

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 250
Est. completion date July 15, 2024
Est. primary completion date May 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Reactive hyperemia-peripheral arterial tonometry Index (RHI )
RHI was assessed by RH-PAT using the EndoPAT2000 system .

Locations
Country Name City State
Tunisia University hospital Fattouma Bourguiba Monastir

Sponsors (1)
Lead Sponsor Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Reactive Hyperemia Index (RHI) RHI is calculated for each participant in the day of iclusion , then it is recalculated in the two others visits. the day of inclusion , 10 last day of Ramadan , 1 month after Ramadan
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