Effects of Ramadan Fasting on Endothelial Function

NCT05331443 | Unknown

• 1 other identifier: RHIFasting
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fasting; Endothelial Dysfunction

Keywords

Ramadan Fasting; Endo-pat

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

participents who has the intention to fast Ramadan

subjects with at least two cardiovascular risk factors according to Framingham classification or with out any risk .

Diagnostic Test: Reactive hyperemia-peripheral arterial tonometry Index (RHI )

Interventions

Reactive hyperemia-peripheral arterial tonometry Index (RHI ) DIAGNOSTIC_TEST

RHI was assessed by RH-PAT using the EndoPAT2000 system .

participents who has the intention to fast Ramadan

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stable patients that intend to fast Ramadan. Each participant is examined during three planned visits. The first takes place during the month preceding Ramadan. The second during the last week of Ramadan and the third thirty days after the end of Ramadan. 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-patient clinic (Cardiology, Endocrinology) at the emergency department of Fattouma Bourguiba university hospital after a clarified written consent.

You may qualify if:

• Adult patient intending to fast Ramadan.

You may not qualify if:

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

Sponsors & Collaborators

• University of Monastir: lead

Study Sites (1)

University hospital Fattouma Bourguiba

Monastir, 5000, Tunisia

Location

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Semir Nouira, Professor

  University of Monastir

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 15, 2022
• Study Start: March 15, 2022
• Primary Completion: May 30, 2023
• Study Completion: July 15, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

TU (1)