Non Invasive Measurement of the Haemodynamic Parameters and of the Advanced Glycation End Products (AGEs) Levels (NONINVASHEMO)

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.

Study Overview

• Status: Completed
• Conditions: Hemodynamic Instability; Skin and Subcutaneous Tissue Disorders
• Intervention / Treatment: Dietary supplement: caffeine intake; Other: cigarette smoking; Other: Caffeine intake and Cigarette smoking

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 Type: Interventional
• Enrollment (Actual): 178
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Lamia, Greece, 35100
    • Technological Educational Institute of Sterea Ellada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Individuals suffering from any chronic disease (diabetes mellitus, cardiovascular diseases, etc)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Caffeine intake; 100mg of Caffeine intake	Dietary supplement: caffeine intake; 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.
Experimental: Cigarette smoking; smoking of one cigarette	Other: cigarette smoking; 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.
Experimental: Caffeine intake and Cigarette smoking; 100mg of Caffeine intake and smoking of one cigarette	Other: cigarette smoking; 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.; Other: Caffeine intake and Cigarette smoking; 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.
No Intervention: Control group; no intervention group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	0 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	60 min

Collaborators and Investigators

• Sponsor: Technological Education Institute of Sterea Ellada
• Collaborators: European Union
• Investigators: Study Director: Anna Deltsidou, PhD, Technological Educational Institute of Athens, Greece

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: August 22, 2015
• First Submitted That Met QC Criteria: September 4, 2015
• First Posted (Estimate): September 9, 2015

Study Record Updates

• Last Update Posted (Estimate): September 9, 2015
• Last Update Submitted That Met QC Criteria: September 4, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: smoking; caffeine intake; haemodynamic parameters; Advanced Glycation End Products (AGEs); Non-invasive measurements devices
• Additional Relevant MeSH Terms: Skin Diseases; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Caffeine
• Other Study ID Numbers: 0925-0586