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Enrolling by invitationNCT05331443Updated Nov 18, 2023

Effects of Ramadan Fasting on Endothelial Function

An observational study in Fasting and Endothelial Dysfunction, sponsored by University of Monastir. Enrolling by invitation at 1 site in Tunisia. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-18.

Sponsored by University of Monastir · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Ages
18 Years to 99 Years
Sex
All
01

Study summary

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

Read the 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 .

02

Conditions studied

  • Fasting
  • Endothelial Dysfunction

Keywords

  • Ramadan Fasting
  • Endo-pat
03

In context

Lead sponsor

University of Monastir is the lead sponsor of 112 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Inclusion criteria

  • Adult patient intending to fast Ramadan.

Exclusion criteria

Exclusion Criteria:

  • Age \< 18 years old
  • Hemodynamic instability.
  • Myocardial infarction requiring urgent revascularization.
  • Parkinsonism: tremor problem.
  • Refusal, communication problem.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (estimated)
Target follow-up
3 Months
Patient registry
Yes

Groups and cohorts

  • 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

  • Diagnostic testReactive hyperemia-peripheral arterial tonometry Index (RHI )

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

06

What researchers measure

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.

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

07

Study locations

1 site
  • University hospital Fattouma Bourguiba
    Monastir, 5000, Tunisia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05331443
Lead sponsor
University of Monastir
Responsible party
Pr. Semir Nouira (Professor, University of Monastir) — Principal investigator
First posted
Apr 15, 2022
Start date
Mar 15, 2022
Primary completion
May 30, 2023
Completion
Jul 15, 2024 (estimated)
Last update
Nov 18, 2023

Study contacts

Semir Nouira, Professor
principal investigator · University of Monastir

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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