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

NCT06009939 | Completed

• 1 other identifier: 2023-01
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (4)

• Speed-resolved perfusion

  \[% RBC ×mm/s\]

  Measured during 45 minutes and at one more occasion for 45 minutes within one week.

• Red blood cell tissue fraction

  \[% RBC\]

  Measured during 45 minutes and at one more occasion for 45 minutes within one week.

• Oxygen saturation

  \[% oxygen\]

  Measured during 45 minutes and at one more occasion for 45 minutes within one week.

• Vessel diameter

  \[μm\]

  Measured during 45 minutes and at one more occasion for 45 minutes within one week.

Study Arms (4)

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

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

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

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

Interventions

Occlusion of the circulation in the arm and foot OTHER

A blood pressure cuff occludes the circulation in the upper arm as well as around the ankle.

Healthy men aged 20-30 years old; Healthy men aged 50-60 years old; Healthy women aged 20-30 years old; Healthy women aged 50-60 years old

Eligibility Criteria

• Age: 20 Years - 60 Years
• Gender Eligibility Details: Since the investigators aim to study potential differences between men and women an equal number of men and women needs to be included in the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

12 healthy men and 12 healthy women aged 20-30 years old. 12 healthy men and 12 healthy women aged 50-60 years old. In total 48 participants will be included.

You may qualify if:

• Men and women between 20-30 years old and 50-60 years old

You may not qualify if:

• Regular use of medication (except for anti-conception medication)
• Hypertension
• Skin- or cardiovascular disease

Sponsors & Collaborators

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

Study Sites (1)

Linköping University

Linköping, Östergötland County, 58185, Sweden

Location

Related Publications (4)

• Hultman M, Larsson M, Stromberg T, Henricson J, Iredahl F, Fredriksson I. Flowmotion imaging analysis of spatiotemporal variations in skin microcirculatory perfusion. Microvasc Res. 2023 Mar;146:104456. doi: 10.1016/j.mvr.2022.104456. Epub 2022 Nov 18. No abstract available.

  PMID: 36403668 BACKGROUND

• Fredriksson I, Larsson M, Stromberg T, Iredahl F. Vasomotion analysis of speed resolved perfusion, oxygen saturation, red blood cell tissue fraction, and vessel diameter: Novel microvascular perspectives. Skin Res Technol. 2022 Jan;28(1):142-152. doi: 10.1111/srt.13106. Epub 2021 Nov 10.

  PMID: 34758168 BACKGROUND

• Hultman M, Larsson M, Stromberg T, Fredriksson I. Real-time video-rate perfusion imaging using multi-exposure laser speckle contrast imaging and machine learning. J Biomed Opt. 2020 Nov;25(11):116007. doi: 10.1117/1.JBO.25.11.116007.

  PMID: 33191685 BACKGROUND

• Hultman M, Larsson M, Stromberg T, Fredriksson I. Speed-resolved perfusion imaging using multi-exposure laser speckle contrast imaging and machine learning. J Biomed Opt. 2023 Mar;28(3):036007. doi: 10.1117/1.JBO.28.3.036007. Epub 2023 Mar 20.

  PMID: 36950019 BACKGROUND

Study Officials

• Fredrik Iredahl

  Linköping University, Department of Health, Medicine and Caring Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 24, 2023
• Study Start: March 1, 2023
• Primary Completion: September 14, 2023
• Study Completion: September 14, 2023
• Last Updated: September 18, 2023

Record last verified: 2023-09

Locations

SE (1)