FastingNCT05331443
Effects of Ramadan Fasting on Endothelial Function
An observational study of Fasting and Endothelial Dysfunction, run by University of Monastir at 1 site in Tunisia.
Trial summary
Include participants who intend to practice Ramadan fasting and accept to complete the three part of the study . Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Fasting, Endothelial Dysfunction
- What is being tested?
- Reactive hyperemia-peripheral arterial tonometry Index (RHI )
- How many people
- 250 participants
- Where
- 1 siteTunisia
- Study dates
- 15 Mar 2022to 15 Jul 2024
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Adult patient intending to fast Ramadan.
Who cannot join
- Age < 18 years old
- Hemodynamic instability.
- Myocardial infarction requiring urgent revascularization.
- Parkinsonism: tremor problem.
- Refusal, communication problem.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- The week before Ramadan (Pre-R).
- the last week of Ramadan (R).
- 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
- Fasting, Endothelial Dysfunction
- Being tested
- Reactive hyperemia-peripheral arterial tonometry Index (RHI )
- Keywords
- Ramadan Fasting, Endo-pat
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reactive hyperemia-peripheral arterial tonometry Index (RHI )Diagnostic test
RHI was assessed by RH-PAT using the EndoPAT2000 system .
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: Diagnostic Test: Reactive hyperemia-peripheral arterial tonometry Index (RHI ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: the day of inclusion , 10 last day of Ramadan , 1 month after Ramadan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start15 Mar 2022
- Primary completion30 May 2023
- Study completion15 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FastingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- Semir Nouira, Professor, Principal investigator, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331443
- Sponsor's protocol ID
- RHIFasting
- Status last verified
- Nov 2023
- First submitted
- 11 Apr 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ramadan Fasting on Endothelial Function
- ClinicalTrials.gov ID
- NCT05331443
- Acronym / sponsor ID
- RHIFasting
- Conditions
- Fasting, Endothelial Dysfunction
- Keywords
- Ramadan Fasting, Endo-pat
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 15 Jul 2024 (estimated)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Include participants who intend to practice Ramadan fasting and accept to complete the three part of the study .
Detailed description
All volunteers and stable patients that intend to fast ramadan. Each participant is examined during three separate visits.
- The week before Ramadan (Pre-R).
- the last week of Ramadan (R).
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| participents who has the intention to fast Ramadan | – | Diagnostic Test: Reactive hyperemia-peripheral arterial tonometry Index (RHI )subjects with at least two cardiovascular risk factors according to Framingham classification or with out any risk . |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Adult patient intending to fast Ramadan.
Key exclusion criteria (5 listed)
- Age < 18 years old
- Hemodynamic instability.
- Myocardial infarction requiring urgent revascularization.
- Parkinsonism: tremor problem.
- Refusal, communication problem.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reactive hyperemia-peripheral arterial tonometry Index (RHI )RHI was assessed by RH-PAT using the EndoPAT2000 system . | Diagnostic test | participents who has the intention to fast Ramadan |
Primary outcome
Change in Reactive Hyperemia Index (RHI)
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Semir Nouira, Professor principal investigator
University of Monastir
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fasting and Endothelial Dysfunction, run by University of Monastir at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Reactive Hyperemia Index (RHI) (time frame: the day of inclusion , 10 last day of Ramadan , 1 month after Ramadan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.