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

Primary Purpose

Hemodynamic Instability, Skin and Subcutaneous Tissue Disorders

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
caffeine intake
cigarette smoking
Caffeine intake and Cigarette smoking
Sponsored by
Technological Education Institute of Sterea Ellada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hemodynamic Instability focused on measuring smoking, caffeine intake, haemodynamic parameters, Advanced Glycation End Products (AGEs), Non-invasive measurements devices

Eligibility Criteria

19 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Technological Educational Institute of Sterea Ellada

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Caffeine intake

Cigarette smoking

Caffeine intake and Cigarette smoking

Control group

Arm Description

100mg of Caffeine intake

smoking of one cigarette

100mg of Caffeine intake and smoking of one cigarette

no intervention group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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

Full Information

First Posted
August 22, 2015
Last Updated
September 4, 2015
Sponsor
Technological Education Institute of Sterea Ellada
Collaborators
European Union
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1. Study Identification

Unique Protocol Identification Number
NCT02544165
Brief Title
Non Invasive Measurement of the Haemodynamic Parameters and of the Advanced Glycation End Products (AGEs) Levels
Acronym
NONINVASHEMO
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Technological Education Institute of Sterea Ellada
Collaborators
European Union

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodynamic Instability, Skin and Subcutaneous Tissue Disorders
Keywords
smoking, caffeine intake, haemodynamic parameters, Advanced Glycation End Products (AGEs), Non-invasive measurements devices

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
178 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Caffeine intake
Arm Type
Experimental
Arm Description
100mg of Caffeine intake
Arm Title
Cigarette smoking
Arm Type
Experimental
Arm Description
smoking of one cigarette
Arm Title
Caffeine intake and Cigarette smoking
Arm Type
Experimental
Arm Description
100mg of Caffeine intake and smoking of one cigarette
Arm Title
Control group
Arm Type
No Intervention
Arm Description
no intervention group
Intervention Type
Dietary Supplement
Intervention Name(s)
caffeine intake
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
cigarette smoking
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Caffeine intake and Cigarette smoking
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measurements of the haemodynamic parameters and accumulation of AGEs before smoking and before intake of caffeine
Description
Measurements of the haemodynamic parameters and accumulation of AGEs before smoking of one cigarette and consumption of 100 mg caffeine
Time Frame
0 min
Secondary Outcome Measure Information:
Title
Changes in the haemodynamic parameters and accumulation of AGEs after consuming 100 mg of caffeine
Description
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
Time Frame
60 min
Title
Changes in the haemodynamic parameters and accumulation of AGEs after smoking of one cigarette
Description
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
Time Frame
60 min
Title
Changes in the haemodynamic parameters and in the accumulation of AGEs after smoking of one cigarette and after consuming of 100 mg caffeine
Description
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
Time Frame
60 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Deltsidou, PhD
Organizational Affiliation
Technological Educational Institute of Athens, Greece
Official's Role
Study Director
Facility Information:
Facility Name
Technological Educational Institute of Sterea Ellada
City
Lamia
ZIP/Postal Code
35100
Country
Greece

12. IPD Sharing Statement

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

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