Microvascular Sex and Age-related Day-to-day Variability in Healthy Subjects

Sponsor
Vårdcentralen Åby (Other)
Overall Status
Recruiting
CT.gov ID
NCT06009939
Collaborator
Department of Biomedical Engineering (IMT) (Other), Department of Health, Medicine and Caring Sciences (HMV) (Other), Linkoeping University (Other)
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Study Details

Study Description

Brief Summary

The goal of this observational study is to learn more about the microcirculation in the skin by examining sex and age-related day-to-day variability in healthy subjects. The main questions the trial aims to answer are:

  • What is the day-to-day variability of the optical measurement techniques in the microcirculation, and does age and gender affect this?

  • Does the day-to-day variability differ in the foot compared to the arm?

Participants will rest whilst skin measurement by optical measurement techniques are performed. Baseline measurements and post-occlusive reactive hyperemia will be studied on the forearm and foot. This measurement procedure is repeated within one week, in order to study variability.

Condition or Disease Intervention/Treatment Phase
  • Other: Occlusion of the circulation in the arm and foot

Detailed Description

The microcirculation consists of arterioles, capillaries and venules and is essential for nutrients and oxygen to be delivered to the tissue as well as waste products to be removed. The skin is often used as a model for studying microcirculation.

There are many different ways to study the microcirculation, most commonly are noninvasive optical techniques which measures the reflection of light used. Laser Doppler Flowmetry (LDF) has been the golden standard, but one limitation with the technique is that it measures the bloodflow in a small area (about 1 mm3). In this study we will be using single-point measurement with a technique called EPOS and larger area measurements with a technique called PSI-X. EPOS, based on LDF and diffuse reflectance spectroscopy (DRS), analyze speed-resolved perfusion, variations in red blood cell tissue fraction, oxygen saturation and vessel diameter. PSI-X, based on multi-exposure laser speckle contrast imaging (MELSCI) and multispectral imaging (MSI), analyze conventional perfusion, speed-resolved perfusion and oxygen saturation.

Flowmotion is the rhythmical variations in measured skin blood flow that arise due to global and local regulation of the vessels and can be studied using frequency analysis of time-resolved blood flow signals. Since EPOS and PSI-X collect data of time-resolved blood flow, flowmotion analysis will also be conducted in the study.

To study day-to-day variability, data will be collected from each subject on two separate days within seven days, on the same location of the foot as well as the arm. Once the subject arrives to the lab, he or she will fill out a questionnaire regarding his/her physical activity level, how often he/ she exercises as well as his/her usage of medication and nicotine. The subject will also confirm that he/she have not eaten two hours and not used nicotine or caffeine three hours prior to the experiment. Thereafter the subject's length and weight will be measured and BMI calculated. The subjects skin type will be determined using the Fitzpatrick scale. All of this is only done on the first day of measurement, on the second day the subject will skip right to the following part.

An acclimatization period of 15 minutes begins and the subject will remove socks and lay down. While the subject rests the equipment will be set up. A blood pressure cuff is placed around the upper arm as well as around the ankle. An EPOS-probe is placed on the dorsal side of the foot as well as the volar side of the forearm. A marker pen is used to mark the skin around the probes which enables the probe to be placed on the same location on the next measurement. Once five minutes has passed, the subjects blood pressure and pulse is noted. Thereafter the PSI-X camera is set up and angled to film the plantar side of the foot from a distance of about 25 cm. The subject is asked to lay as still as possible during the measurement. Once the acclimatization period has passed, the lights in the lab are turned off and the measurement will begin. Firstly baseline data will be collected as the subject rest for 10 minutes without provocation. Thereafter the blood pressure cuff on the ankle will inflate to 250 mmHg for five minutes whilst data is collected. Lastly data is collected for five minutes after the blood pressure cuff deflates. Thereafter the PSI-X camera is moved and angled to film the forearm from a 25 cm distance. The protocol described above is repeated for the arm. The subject will return within seven days to repeat the data collection protocol.

Study Design

Study Type:
Observational
Anticipated Enrollment :
48 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Microvascular Sex and Age-related Day-to-day Variability in Healthy Subjects
Actual Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Oct 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Healthy men aged 20-30 years old

Foot: 10 minutes of baseline measurement, 5 minutes of occlusion and 5 minutes of Post-occlusive reactive hyperemia (PORH) measurement. Arm: 10 minutes of baseline measurement, 5 minutes of occlusion and 5 minutes of Post-occlusive reactive hyperemia (PORH) measurement.

Other: Occlusion of the circulation in the arm and foot
A blood pressure cuff occludes the circulation in the upper arm as well as around the ankle.

Healthy women aged 20-30 years old

Foot: 10 minutes of baseline measurement, 5 minutes of occlusion and 5 minutes of Post-occlusive reactive hyperemia (PORH) measurement. Arm: 10 minutes of baseline measurement, 5 minutes of occlusion and 5 minutes of Post-occlusive reactive hyperemia (PORH) measurement.

Other: Occlusion of the circulation in the arm and foot
A blood pressure cuff occludes the circulation in the upper arm as well as around the ankle.

Healthy men aged 50-60 years old

Foot: 10 minutes of baseline measurement, 5 minutes of occlusion and 5 minutes of Post-occlusive reactive hyperemia (PORH) measurement. Arm: 10 minutes of baseline measurement, 5 minutes of occlusion and 5 minutes of Post-occlusive reactive hyperemia (PORH) measurement.

Other: Occlusion of the circulation in the arm and foot
A blood pressure cuff occludes the circulation in the upper arm as well as around the ankle.

Healthy women aged 50-60 years old

Foot: 10 minutes of baseline measurement, 5 minutes of occlusion and 5 minutes of Post-occlusive reactive hyperemia (PORH) measurement. Arm: 10 minutes of baseline measurement, 5 minutes of occlusion and 5 minutes of Post-occlusive reactive hyperemia (PORH) measurement.

Other: Occlusion of the circulation in the arm and foot
A blood pressure cuff occludes the circulation in the upper arm as well as around the ankle.

Outcome Measures

Primary Outcome Measures

  1. Speed-resolved perfusion [Measured during 45 minutes and at one more occasion for 45 minutes within one week.]

    [% RBC ×mm/s]

  2. Red blood cell tissue fraction [Measured during 45 minutes and at one more occasion for 45 minutes within one week.]

    [% RBC]

  3. Oxygen saturation [Measured during 45 minutes and at one more occasion for 45 minutes within one week.]

    [% oxygen]

  4. Vessel diameter [Measured during 45 minutes and at one more occasion for 45 minutes within one week.]

    [μm]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Men and women between 20-30 years old and 50-60 years old
Exclusion Criteria:
  • Regular use of medication (except for anti-conception medication)

  • Hypertension

  • Skin- or cardiovascular disease

Contacts and Locations

Locations

Site City State Country Postal Code
1 Linköping University Linköping Östergötland Sweden 58185

Sponsors and Collaborators

  • Vårdcentralen Åby
  • Department of Biomedical Engineering (IMT)
  • Department of Health, Medicine and Caring Sciences (HMV)
  • Linkoeping University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Fredrik Iredahl, Associate Professor, Vårdcentralen Åby
ClinicalTrials.gov Identifier:
NCT06009939
Other Study ID Numbers:
  • 2023-01
First Posted:
Aug 24, 2023
Last Update Posted:
Aug 24, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 24, 2023