Cardiovascular Risk FactorsNCT02720133
Ramadan Fasting Effects in Patients With Cardiovascular Risk Factors
An observational study of Cardiovascular Risk Factors and Fasting, run by University of Monastir at 1 site in Tunisia.
Trial summary
Ramadan Fasting has multiple effects on the variation of hematological and biochemical parameters. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factors, Fasting
- What is being tested?
- biochemical parameters
- How many people
- 500 participants
- Where
- 1 siteTunisia
- Study dates
- Jul 2013to Sep 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Stable patients with cardiovascular risk factors who fast during Ramadan
Who may be able to join
- Patients with cardiovascular risk factors in stable conditions
- Ramadan fasting
Who cannot join
- Impossibility, contraindication or interruption of fasting
Trial locations and contacts
1 site in 1 country.
About this study
Ramadan Fasting has multiple effects on the variation of hematological and biochemical parameters.
Read the detailed description
This is a prospective observational study, including patients with cardiovascular risk factors and doing the fast of Ramadan with assessment before, during and after the month of Ramadan.
- Conditions
- Cardiovascular Risk Factors, Fasting
- Being tested
- biochemical parameters
- Keywords
- ramadan fasting, variation of biochemical parameters, variation of hematological parameters, verify now assay
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biochemical parametersBiological
Also called hematological parameters assay, verify now assay
patients will be collected for analysis of blood standard examinations such as blood glucose, electrolytes (potassium, sodium, magnesium calcium), renal function and also the blood count, platelet aggregation.
All these tests should be practice before, during and after Ramadan fasting for comparison.
| Study group | Role | What they receive |
|---|---|---|
| Patients with cardiovascular risk factors who fast Ramadan | Stable clinical and biochemical parameters before Ramadan fasting Receives: Biological: biochemical parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause clinical complications
Measured: 5 years
Secondary outcomes (1)
evidence of acute coronary complications
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startJul 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorsStudies 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
- 500 participants (actual)
- 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, Pr., Principal investigator, University Hospital Of Monastir Tunisia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720133
- Sponsor's protocol ID
- GR2
- Status last verified
- Jun 2016
- First submitted
- 24 Jul 2014
- Last updated
- 20 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Attarzadeh Hosseini SR, Hejazi K. The effects of ramadan fasting and physical activity on blood hematological-biochemical parameters. Iran J Basic Med Sci. 2013 Jul;16(7):845-9.
PubMed 23997915Bouida W, Beltaief K, Baccouche H, Sassi M, Dridi Z, Trabelsi I, Laaouiti K, Chakroun T, Hellara I, Boukef R, Sakly N, Hassine M, Added F, Razgallah R, Najjar F, Nouira S; Ramadan Research Group. Effects of Ramadan fasting on aspirin resistance in type 2 diabetic patients. PLoS One. 2018 Mar 12;13(3):e0192590. doi: 10.1371/journal.pone.0192590. eCollection 2018.
PubMed 29529091Bouida W, Baccouche H, Sassi M, Dridi Z, Chakroun T, Hellara I, Boukef R, Hassine M, Added F, Razgallah R, Khochtali I, Nouira S; Ramadan Research Group. Effects of Ramadan fasting on platelet reactivity in diabetic patients treated with clopidogrel. Thromb J. 2017 Jun 2;15:15. doi: 10.1186/s12959-017-0138-0. eCollection 2017.
PubMed 28588426
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ramadan Fasting Effects in Patients With Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT02720133
- Acronym / sponsor ID
- GR2
- Conditions
- Cardiovascular Risk Factors, Fasting
- Keywords
- ramadan fasting, variation of biochemical parameters, variation of hematological parameters, verify now assay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 25 Mar 2016 (estimated)
- 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.
Ramadan Fasting has multiple effects on the variation of hematological and biochemical parameters.
Detailed description
This is a prospective observational study, including patients with cardiovascular risk factors and doing the fast of Ramadan with assessment before, during and after the month of Ramadan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with cardiovascular risk factors who fast Ramadan | – | Biological: biochemical parametersStable clinical and biochemical parameters before Ramadan fasting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Stable patients with cardiovascular risk factors who fast during Ramadan
Key inclusion criteria (2 listed)
- Patients with cardiovascular risk factors in stable conditions
- Ramadan fasting
Key exclusion criteria (1 listed)
- Impossibility, contraindication or interruption of fasting
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 |
|---|---|---|
| biochemical parametersAlso: hematological parameters assay, verify now assaypatients will be collected for analysis of blood standard examinations such as blood glucose, electrolytes (potassium, sodium, magnesium calcium), renal function and also the blood count, platelet aggregation. All these tests should be practice before, during and after Ramadan fasting for comparison. | Biological | Patients with cardiovascular risk factors who fast Ramadan |
Primary outcome
all cause clinical complications
Time frame: 5 years
1 secondary outcome
evidence of acute coronary complications
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2016.
- Results publication: PubMed 23997915Attarzadeh Hosseini SR, Hejazi K. The effects of ramadan fasting and physical activity on blood hematological-biochemical parameters. Iran J Basic Med Sci. 2013 Jul;16(7):845-9.
- Derived from this study: PubMed 29529091Bouida W, Beltaief K, Baccouche H, Sassi M, Dridi Z, Trabelsi I, Laaouiti K, Chakroun T, Hellara I, Boukef R, Sakly N, Hassine M, Added F, Razgallah R, Najjar F, Nouira S; Ramadan Research Group. Effects of Ramadan fasting on aspirin resistance in type 2 diabetic patients. PLoS One. 2018 Mar 12;13(3):e0192590. doi: 10.1371/journal.pone.0192590. eCollection 2018.
- Derived from this study: PubMed 28588426Bouida W, Baccouche H, Sassi M, Dridi Z, Chakroun T, Hellara I, Boukef R, Hassine M, Added F, Razgallah R, Khochtali I, Nouira S; Ramadan Research Group. Effects of Ramadan fasting on platelet reactivity in diabetic patients treated with clopidogrel. Thromb J. 2017 Jun 2;15:15. doi: 10.1186/s12959-017-0138-0. eCollection 2017.
- The effects of ramadan fasting and physical activity on glycemic control, lipid metabolism, and the effects clopidogrel and aspirin activityameters.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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, Pr. principal investigator
University Hospital Of Monastir Tunisia
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 Cardiovascular Risk Factors and Fasting, 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 20 Jun 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
all cause clinical complications (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02720133, which also lists 3 linked publications.
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 20 Jun 2016.