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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Greece1 site
  • Technological Educational Institute of Sterea Ellada

    Lamia, 35100

Other trials in Greece

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 groups in NCT02544165
Study groupRoleWhat they receive
Caffeine intakeExperimental100mg of Caffeine intake
Receives: Dietary Supplement: caffeine intake
Cigarette smokingExperimentalsmoking of one cigarette
Receives: Other: cigarette smoking
Caffeine intake and Cigarette smokingExperimental100mg of Caffeine intake and smoking of one cigarette
Receives: Other: cigarette smoking; Other: Caffeine intake and Cigarette smoking
Control groupNo interventionno intervention group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted9 Sep 2015 (estimated)
  2. Study startNov 2012
  3. Primary completionJan 2013
  4. Study completionJun 2014

Resources

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)
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

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; AzTrials last refreshed its copy on 8 Nov 2026.

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