Effects of Ramadan Fasting on Endothelial Function

NCT ID: NCT05331443

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-15

Study Completion Date

2024-07-15

Brief Summary

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

Detailed Description

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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 .

Conditions

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Fasting Endothelial Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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 .

Reactive hyperemia-peripheral arterial tonometry Index (RHI )

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Reactive hyperemia-peripheral arterial tonometry Index (RHI )

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Monastir

OTHER

Sponsor Role lead

Responsible Party

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Pr. Semir Nouira

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Semir Nouira, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Monastir

Locations

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University hospital Fattouma Bourguiba

Monastir, , Tunisia

Site Status

Countries

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Tunisia

Other Identifiers

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RHIFasting

Identifier Type: -

Identifier Source: org_study_id

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