Hemodynamic InstabilityNONINVASHEMONCT02544165
Non Invasive Measurement of the Haemodynamic Parameters and of the Advanced Glycation End Products (AGEs) Levels
A study testing caffeine intake, cigarette smoking and Caffeine intake and Cigarette smoking in people with Hemodynamic Instability and Skin and Subcutaneous Tissue Disorders, run by Technological Education Institute of Sterea Ellada at 1 site in Greece.
Trial summary
The aim of this study was to investigate the difference in accumulation of AGEs (advanced glycation end-products) in the tissues of individuals who smoke in comparison with individuals who do not as well as of individuals who consume caffeine versus those who do not, and finally to examine the probable differences… Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodynamic Instability, Skin and Subcutaneous Tissue Disorders
- What is being tested?
- caffeine intake, cigarette smoking and Caffeine intake and Cigarette smoking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteGreece
- Study dates
- Nov 2012to Jun 2014
- Phase
- Interventional
- 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 19 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals who smoke ≥ 10 cigarettes per day
- Healthy non smoking individuals consuming caffeine on daily basis
- Healthy individuals, smoking and consuming caffeine on daily basis
Who cannot join
- Individuals suffering from any chronic disease (diabetes mellitus, cardiovascular diseases, etc)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non Invasive Measurement of the Haemodynamic Parameters and of the Advanced Glycation End Products (AGEs) Levels in Students Smokers and in Students Who Intake Caffeine (NONINVASHAEMOAGES)
The aim of this study was to investigate the difference in accumulation of AGEs (advanced glycation end-products) in the tissues of individuals who smoke in comparison with individuals who do not as well as of individuals who consume caffeine versus those who do not, and finally to examine the probable differences concerning participants' haemodynamic parameters.
Read the detailed description
Materials and methods Study population The study population consisted of students of Health Care Professions who accepted to participate in the study and gave their informed consent for their participation. The population study included healthy volunteers without cardiovascular problems, other chronic or systemic diseases. Participants were divided into 3 intervention groups: the first group are non-smokers who consume caffeine on daily basis, the second group are smokers who do not consume caffeine on daily basis, and the third group are smokers who consume caffeine on daily basis. Additionally, there was a control group consisting of non smoking students and no caffeine users on daily basis.
Methodology A complete medical history with information about the health status of the subjects, drug use and the main risk factors for cardiovascular conditions was recorded. Details concerning smoking and drinking habits, caffeine intake and other medical conditions and conditions from the individual and family history were retrieved, by filling-in self-reporting questionnaires. Information about dietary habits and physical activity of the subjects was also recorded. Body weight and height of all participants were measured. Also, participants were informed that on the day of the scheduled measurements, they should not have breakfast nor smoke for 2 hours (for smokers) prior to measurements and finally abstain from any physical activity. Inclusion criteria in the group of smokers were cigarette smoking of more than 10 cigarettes/day for at least 2 years.
Skin- autofluorescence measurement Tissue AGEs accumulation was assessed using a validated skin-autofluorescence (skin-AF) device, namely AGE Reader. In short, the AGE reader illuminates a skin surface of approximately 4 cm2, guarded against surrounding light, with an excitation light source between 300 and 420 nm (peak excitation ~370 nm). Skin-AF was measured at the volar side of the lower arm at approximately 10-15 cm below the elbow fold. Care had been taken to perform the measurement at normal skin site (without visible vessels, scars, lichenification, or other skin abnormalities). The investigators performed three measurements with a 5min interval between them and the investigators calculated the mean value of three measurements. For the individuals who smoked, these measurements were repeated 2 hours after the smoking of one cigarette and for individuals who consumed caffeine, measurements were repeated after the intake of 100 mg caffeine (delivered as a beverage). This was done to check whether there was a change in accumulation of AGEs following cigarette smoking and caffeine intake.
Haemodynamic parameters' measurement The haemodynamic parameters' measurement included measurement of cardiac output, stroke volume, systolic and diastolic blood pressure, mean pressure, pulse rate, interbeat intervals, arterial compliance and systemic vascular resistance. These measurements were performed with the Finometer device (FMS, Finapress Medical System, BV, Netherlands), while the data were recorded by using the Beatscope, a specially designed software, to transfer data to the PC and to process pressure waveform files. The measurements were performed by using a non-invasive method via a finger cuff, which was wrapped around the finger of the individual, who was in a lying down position for 10 min before the measurements in a room of a sound-attenuated, temperature-controlled environment, in order to ensure that all measurements will be performed under constant and stable conditions. Subsequently, the haemodynamic parameters' measurement was performed for 15 min in a sitting position. Additionally, for smokers the measurements were repeated after 15-30 min since smoking one cigarette and after 45 min for individuals who consumed caffeine.
- Being tested
- caffeine intake, cigarette smoking, Caffeine intake and Cigarette smoking
- Keywords
- smoking, caffeine intake, haemodynamic parameters, Advanced Glycation End Products (AGEs), Non-invasive measurements devices
- Medical subject headings
- Skin Diseases, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caffeine intakeDietary supplement
The subjects of this group should intake 100 mg of caffeine after the first measurement of haemodynamic parameters with the Finometer device and after the first measurement of the advanced glycation end products accumulation with AgeReader device.
cigarette smokingOther
The subjects of this group should smoke one cigarette after the first measurement of haemodynamic parameters with the Finometer device and after the first measurement of the advanced glycation end products accumulation with AgeReader device.
Caffeine intake and Cigarette smokingOther
The subjects of this group should smoke one cigarette and should consume 100 mg of caffeine after the first measurement of haemodynamic parameters with the Finometer device and after the first measurement of the advanced glycation end products accumulation with AgeReader device.
| Study group | Role | What they receive |
|---|---|---|
| Caffeine intake | Experimental | 100mg of Caffeine intake Receives: Dietary Supplement: caffeine intake |
| Cigarette smoking | Experimental | smoking of one cigarette Receives: Other: cigarette smoking |
| Caffeine intake and Cigarette smoking | Experimental | 100mg of Caffeine intake and smoking of one cigarette Receives: Other: cigarette smoking; Other: Caffeine intake and Cigarette smoking |
| Control group | No intervention | no intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurements of the haemodynamic parameters and accumulation of AGEs before smoking and before intake of caffeine
Measurements of the haemodynamic parameters and accumulation of AGEs before smoking of one cigarette and consumption of 100 mg caffeine
Measured: 0 min
Secondary outcomes (3)
Changes in the haemodynamic parameters and accumulation of AGEs after consuming 100 mg of caffeine
Measurement of haemodynamic parameters with finometer device in 45 min after consuming of 100 mg caffeine and measurement of the accumulation of AGEs with the device AgeReader
Measured: 60 min
Changes in the haemodynamic parameters and accumulation of AGEs after smoking of one cigarette
Measurement of haemodynamic parameters with finometer device in 45 min after the smoking of one cigarette and measurement of the accumulation of AGEs with the device AgeReader
Measured: 60 min
Changes in the haemodynamic parameters and in the accumulation of AGEs after smoking of one cigarette and after consuming of 100 mg caffeine
Measurement of haemodynamic parameters with finometer device in 45 min after the smoking of one cigarette and measurement of the accumulation of AGEs with the device AgeReader
Measured: 60 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startNov 2012
- Primary completionJan 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic InstabilityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technological Education Institute of Sterea Ellada
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Responsible party
- Principal investigator, ANNA DELTSIDOU, Technological Education Institute of Athens
- Investigators
- Anna Deltsidou, PhD, Study director, Technological Educational Institute of Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544165
- Sponsor's protocol ID
- 0925-0586
- Acronym
- NONINVASHEMO
- Status last verified
- Sep 2015
- First submitted
- 22 Aug 2015
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Invasive Measurement of the Haemodynamic Parameters and of the Advanced Glycation End Products (AGEs) Levels in Students Smokers and in Students Who Intake Caffeine (NONINVASHAEMOAGES)
- ClinicalTrials.gov ID
- NCT02544165
- Acronym / sponsor ID
- NONINVASHEMO / 0925-0586
- Keywords
- smoking, caffeine intake, haemodynamic parameters, Advanced Glycation End Products (AGEs), Non-invasive measurements devices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Technological Education Institute of Sterea ElladaUniversity, hospital or other
- Collaborators
- European Union
- Study start
- Nov 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 9 Sep 2015 (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.
The aim of this study was to investigate the difference in accumulation of AGEs (advanced glycation end-products) in the tissues of individuals who smoke in comparison with individuals who do not as well as of individuals who consume caffeine versus those who do not, and finally to examine the probable differences concerning participants' haemodynamic parameters.
Detailed description
Materials and methods Study population The study population consisted of students of Health Care Professions who accepted to participate in the study and gave their informed consent for their participation. The population study included healthy volunteers without cardiovascular problems, other chronic or systemic diseases. Participants were divided into 3 intervention groups: the first group are non-smokers who consume caffeine on daily basis, the second group are smokers who do not consume caffeine on daily basis, and the third group are smokers who consume caffeine on daily basis. Additionally, there was a control group consisting of non smoking students and no caffeine users on daily basis.
Methodology A complete medical history with information about the health status of the subjects, drug use and the main risk factors for cardiovascular conditions was recorded. Details concerning smoking and drinking habits, caffeine intake and other medical conditions and conditions from the individual and family history were retrieved, by filling-in self-reporting questionnaires. Information about dietary habits and physical activity of the subjects was also recorded. Body weight and height of all participants were measured. Also, participants were informed that on the day of the scheduled measurements, they should not have breakfast nor smoke for 2 hours (for smokers) prior to measurements and finally abstain from any physical activity. Inclusion criteria in the group of smokers were cigarette smoking of more than 10 cigarettes/day for at least 2 years.
Skin- autofluorescence measurement Tissue AGEs accumulation was assessed using a validated skin-autofluorescence (skin-AF) device, namely AGE Reader. In short, the AGE reader illuminates a skin surface of approximately 4 cm2, guarded against surrounding light, with an excitation light source between 300 and 420 nm (peak excitation ~370 nm). Skin-AF was measured at the volar side of the lower arm at approximately 10-15 cm below the elbow fold. Care had been taken to perform the measurement at normal skin site (without visible vessels, scars, lichenification, or other skin abnormalities). The investigators performed three measurements with a 5min interval between them and the investigators calculated the mean value of three measurements. For the individuals who smoked, these measurements were repeated 2 hours after the smoking of one cigarette and for individuals who consumed caffeine, measurements were repeated after the intake of 100 mg caffeine (delivered as a beverage). This was done to check whether there was a change in accumulation of AGEs following cigarette smoking and caffeine intake.
Haemodynamic parameters' measurement The haemodynamic parameters' measurement included measurement of cardiac output, stroke volume, systolic and diastolic blood pressure, mean pressure, pulse rate, interbeat intervals, arterial compliance and systemic vascular resistance. These measurements were performed with the Finometer device (FMS, Finapress Medical System, BV, Netherlands), while the data were recorded by using the Beatscope, a specially designed software, to transfer data to the PC and to process pressure waveform files. The measurements were performed by using a non-invasive method via a finger cuff, which was wrapped around the finger of the individual, who was in a lying down position for 10 min before the measurements in a room of a sound-attenuated, temperature-controlled environment, in order to ensure that all measurements will be performed under constant and stable conditions. Subsequently, the haemodynamic parameters' measurement was performed for 15 min in a sitting position. Additionally, for smokers the measurements were repeated after 15-30 min since smoking one cigarette and after 45 min for individuals who consumed caffeine.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Caffeine intake | Experimental | Dietary Supplement: caffeine intake100mg of Caffeine intake |
| Cigarette smoking | Experimental | Other: cigarette smokingsmoking of one cigarette |
| Caffeine intake and Cigarette smoking | Experimental | Other: cigarette smoking, Other: Caffeine intake and Cigarette smoking100mg of Caffeine intake and smoking of one cigarette |
| Control group | No intervention | –no intervention group |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy individuals who smoke ≥ 10 cigarettes per day
- Healthy non smoking individuals consuming caffeine on daily basis
- Healthy individuals, smoking and consuming caffeine on daily basis
Key exclusion criteria (1 listed)
- Individuals suffering from any chronic disease (diabetes mellitus, cardiovascular diseases, etc)
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 |
|---|---|---|
| caffeine intakeThe subjects of this group should intake 100 mg of caffeine after the first measurement of haemodynamic parameters with the Finometer device and after the first measurement of the advanced glycation end products accumulation with AgeReader device. | Dietary supplement | Caffeine intake |
| cigarette smokingThe subjects of this group should smoke one cigarette after the first measurement of haemodynamic parameters with the Finometer device and after the first measurement of the advanced glycation end products accumulation with AgeReader device. | Other | Caffeine intake and Cigarette smoking, Cigarette smoking |
| Caffeine intake and Cigarette smokingThe subjects of this group should smoke one cigarette and should consume 100 mg of caffeine after the first measurement of haemodynamic parameters with the Finometer device and after the first measurement of the advanced glycation end products accumulation with AgeReader device. | Other | Caffeine intake and Cigarette smoking |
Primary outcome
Measurements of the haemodynamic parameters and accumulation of AGEs before smoking and before intake of caffeine
Time frame: 0 min
Measurements of the haemodynamic parameters and accumulation of AGEs before smoking of one cigarette and consumption of 100 mg caffeine
3 secondary outcomes
Changes in the haemodynamic parameters and accumulation of AGEs after consuming 100 mg of caffeine
Time frame: 60 min
Changes in the haemodynamic parameters and accumulation of AGEs after smoking of one cigarette
Time frame: 60 min
Changes in the haemodynamic parameters and in the accumulation of AGEs after smoking of one cigarette and after consuming of 100 mg caffeine
Time frame: 60 min
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 9 Sep 2015.
Related trials for Hemodynamic Instability
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
Not yet recruitingObservational study
Ultrasound-Calibrated Pulse Contour Cardiac Output Monitoring: Value and Accuracy in Hemodynamic Care
Sepsis, Circulatory Instability
RecruitingObservational study
Comparison of PPV and LVOT VTI During Passive Leg Raising to Predict Fluid Responsiveness
Hemodynamic Instability, Hypovolemia
Not yet recruiting
Intracuff Dexmedetomidine Versus Alkalinized Lidocaine for Peri-Extubation Cough and Hemodynamic Responses in Elderly Patients
Airway Complication of Anesthesia, Hemodynamic Instability
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
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.
Anna Deltsidou, PhD study director
Technological Educational Institute of Athens, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing caffeine intake, cigarette smoking and Caffeine intake and Cigarette smoking in people with Hemodynamic Instability and Skin and Subcutaneous Tissue Disorders, run by Technological Education Institute of Sterea Ellada at 1 site in Greece.
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 3 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 9 Sep 2015. 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 Greece. 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?
Measurements of the haemodynamic parameters and accumulation of AGEs before smoking and before intake of caffeine (time frame: 0 min). 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 9 Sep 2015.