Effects of Ramadan Fasting on Endothelial Function

• Sponsor: University of Monastir (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05331443
• Collaborator: (none)
• Enrollment: 250
• Location: 1
• Anticipated Duration (Months): 5.6
• Patients Per Site Per Month: 44.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Fasting; Endothelial Dysfunction	Diagnostic Test: Reactive hyperemia-peripheral arterial tonometry Index (RHI )

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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 250 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Effects of Ramadan Fasting on Endothelial Function
• Actual Study Start Date: Mar 15, 2022
• Anticipated Primary Completion Date: Aug 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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 ); RHI was assessed by RH-PAT using the EndoPAT2000 system .

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University hospital Fattouma Bourguiba	Monastir		Tunisia	5000

Sponsors and Collaborators

• University of Monastir

Investigators

• Principal Investigator: Semir Nouira, Professor, University of Monastir

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pr. Semir Nouira, Professor, University of Monastir
• ClinicalTrials.gov Identifier: NCT05331443
• Other Study ID Numbers: RHIFasting
• First Posted: Apr 15, 2022
• Last Update Posted: Jun 22, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pr. Semir Nouira, Professor, University of Monastir: Ramadan Fasting; Endo-pat

Study Results

No Results Posted as of Jun 22, 2022