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NCT Number: NCT06498791

Functional Mitochondrial Analysis PBMCs

The primary goal of this prospective, exploratory, longitudinal, single-centre, cohort study is to assess the stability of the mitochondrial flux in PBMCs over long-term cryopreservation.

Secondary goals of this study are:

* to identify changes in the mitochondrial respiratory flux in different metabolic states of cryopreserved PBMCs during long-term cryopreservation. * to assess variability between mitochondrial respiration from PBMCs isolated from same volunteers at different times, seasons or from different arms.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University Innsbruck - Department of Neurology

Innsbruck, Tyrol, 6020, Austria

About this study

The analysis of mitochondrial function can also be referred to as a bioenergetic snapshot. Mitochondria are dynamic metabolic organelles that adapt to various physiological demands, reflecting an individual's lifestyle and exposure to environmental factors, medications, and toxins. Numerous studies have shown that mitochondrial respiration declines with age and correlates with many age-related diseases. This raises the question of how mitochondria influence cells in a clinical context.

For this purpose, 20 participants are recruited and comprehensively characterized in terms of their demographic information and clinical profiles. Additionally, physical examinations are conducted, and participants are surveyed about their lifestyles through questionnaires. Over a 12-month period, blood samples are collected at intervals of three months, resulting in a total of five study visits. For the analysis of mitochondrial oxygen consumption, peripheral blood mononuclear cells (PBMCs) are preferably used, as they provide a minimally invasive and easily accessible insight into mitochondrial function and overall metabolic status and are isolated from the collected blood samples.

To enable the application of mitochondrial diagnostics in research for early disease detection and therapeutic development, additional information is needed regarding the stability of mitochondrial respiration in cryopreserved PBMCs using high-resolution respirometry (HRR) with O2k technology. The goal of this study is to assess how the duration of cryopreservation affects mitochondrial bioenergetics compared to freshly isolated PBMCs.

The study also considers a variety of parameters that could potentially influence the stability of mitochondrial respiration. These factors include non-fasting blood collection, discrepancies between the right and left arm, and seasonal effects. To what extent the intraindividual variability in these parameters affects the mitochondrial respiration is yet to be fully understood.

Furthermore, the longitudinal study design allows the tracking of mitochondrial activity and stability over time, providing a better understanding of the central processes of cellular respiration.

Thus, the planned study promises to yield significant insights into mitochondrial respiration and cellular bioenergetics in a clinical context.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged between 18-85
  • Willingness and ability to consent

Exclusion criteria

  • Regular (e.g. daily, weekly or similar) intake of medication or nutritional supplements except oral and spiral contraceptives
  • Autoimmune diseases or immune alterations
  • Diseases in the context of haematopoiesis, haemophilia, hematophobia
  • Diagnosed mild or major neurocognitive disorder
  • Depressive episodes in the last two years
  • Chronic infectious diseases
  • Neurostimulators or drug pump
  • Involved in competitive sports (over the past two years)
  • Pregnancy

Treatment and study plan

Venipuncture

Other

Blood drawing

Questionnaire

Other

Completion of the questionnaire

Primary outcomes

  1. Stability of mitochondrial respiratory flux (O2 flux) in cryopreserved PBMCs

    Time frame: 1 week and every 8 weeks after cryopreservation

    Mitochondrial respiratory flux is assessed by High Resolution Respirometry analysis

  2. Stability of O2 concentration in cryopreserved PBMCs

    Time frame: 1 week and every 8 weeks after cryopreservation

    Mitochondrial respiratory flux is assessed by High Resolution Respirometry analysis

  3. Assessment of mitochondrial respiratory flux (O2 flux) in fresh PBMCs compared to cryopreserved PBMCs

    Time frame: Baseline visit, 3, 6, 9, 12 months visit

    Mitochondrial respiratory flux is assessed by High Resolution Respirometry analysis

  4. Assessment of O2 concentration in fresh PBMCs compared to cryopreserved PBMCs

    Time frame: Baseline visit, 3, 6, 9, 12 months visit

    Mitochondrial respiratory flux is assessed by High Resolution Respirometry analysis

Secondary outcomes

  1. Assessment of O2 flux in fresh and cryopreserved PBMCs in fasted vs non-fasted sampling conditions

    Time frame: 6 months visit

    Assessement of mitochondrial bioenergetic snapshot in fresh and cryopreserved PBMCs at two different collection time points (fasted and non-fasted)

  2. Assessment of O2 flux in fresh and cryopreserved PBMCs at different seasonal collection time points

    Time frame: Baseline visit, 3, 6, 9, 12 months visit

    Assessement of mitochondrial bioenergetic snapshot in fresh and cryopreserved PBMCs in different seasons

  3. Assessment of O2 flux in fresh and cryopreserved PBMCs at different venipuncture sites

    Time frame: 3 months visit

    Assessement of mitochondrial bioenergetic snapshot in fresh and cryopreserved PBMCs collected from left and right arm

  4. Assessment of blood count and differential blood count I

    Time frame: Baseline visit, 3, 6, 9, 12 months visit

    Analysis of complete blood count (e.g. erythrocyte concentration (mg/dL))

  5. Assessment of blood count and differential blood count II

    Time frame: Baseline visit, 3, 6, 9, 12 months visit

    Analysis of complete blood count (e.g. haemoglobin concentration (g/dL))

  6. Concentration of Creatinine and Urea

    Time frame: Baseline visit, 3, 6, 9, 12 months visit

    Creatinine (mg/dL), Urea (mg/dL)

  7. Concentration of Creatine Kinase

    Time frame: Baseline, 6, 12 months visit

    Creatine Kinase (U/L)

  8. Concentration of Glucose

    Time frame: Baseline visit, 3, 6, 9, 12 months visit

    Glucose (mg/dL, mmol/L)

  9. Concentration of HbA1c

    Time frame: Baseline, 6, 12 months visit

    HbA1c (%)

  10. Concentration of Sodium, Potassium, Chloride and Calcium

    Time frame: Baseline, 6, 12 months visit

    Sodium (mmol/L), potassium (mmol/L), chloride (mmol/L), calcium (mmol/L)

  11. Concentration of GOT and GPT

    Time frame: Baseline, 6, 12 months visit

    Glutamic-oxaloacetic transaminase (GOT, U/L), glutamic-pyruvic transaminase (GPT, U/L), gamma-glutamyl-transpeptidase (gamma-GT, U/L), lactate dehydrogenase (LDH, U/L)

  12. Concentration of triglyceride and cholesterol

    Time frame: Baseline, 6, 12 months visit

    Triglyceride (mmol/L), cholesterol (all, mmol/L )

  13. Concentration of LDL-cholesterol and HDL-cholesterol

    Time frame: Baseline, 6, 12 months visit

    LDL-cholesterol (mg/dL), HDL-cholesterol (mg/dL)

  14. Concentration of Lipoprotein a

    Time frame: Baseline visit

    Lipoprotein a (mg/dL)

  15. Assessment of Sedimentation rate

    Time frame: Baseline, 12 months visit

    Sedimentation rate (mm/h)

  16. Concentration of C-reactive protein

    Time frame: Baseline visit, 3, 6, 9, 12 months visit

    CRP sensitive (mg/L)

  17. Concentration of Interleukin-6

    Time frame: Baseline, 6, 12 months visit

    Interleukin-6 (pg/ml)

  18. Concentration of Thyroid-stimulating hormone

    Time frame: Baseline, 12 months visit

    TSH (mU/mL)

  19. Concentration of Iric acid

    Time frame: Baseline, 12 months visit

    Uric acid (mg/dL)

  20. Concentration of Ferritin

    Time frame: Baseline, 12 months visit

    Ferritin (ng/mL, μg/L)

Other outcomes

  1. Demographic data I

    Time frame: Baseline visit

    Assessment of demographic data such as current age, sex at birth, location of birth

  2. Demographic data II

    Time frame: Baseline visit

    Assessment of demographic data such as: height (cm)

  3. Demographic data III

    Time frame: Baseline visit

    Assessment of demographic data such as: weight (kg)

  4. Demographic data - Personal background and lifestyle I

    Time frame: Baseline visit

    Assessment of demographic data with focus on personal background and lifestyle: e.g.

    • ethnicity (anamnesis)
    • marital/relationship status (anamnesis)
    • number of children (anamnesis)
    • highest level of education (anamnesis)
  5. Menstrual cycle duration (women only)

    Time frame: Baseline visit, 3, 6, 9, 12 months visit

    Assessment of menstrual cycle with focus on cycle duration (in days)

  6. Menstrual cycle length (women only)

    Time frame: Baseline visit, 3, 6, 9, 12 months visit

    Assessment of menstrual cycle with focus on the initiation of the last cycle (day)

  7. Demographic data - Personal background and lifestyle II

    Time frame: Baseline visit, 3, 6, 9, 12 months visit

    Assessment of demographic data with focus on personal background and lifestyle: smoking and smoking history, alcohol consumption and diet

  8. Demographic data - Personal background and lifestyle III

    Time frame: Baseline visit, 3, 6, 9, 12 months visit

    Assessment of demographic data with focus on personal background and lifestyle: amount and intensity of physical activity

  9. Demographic data - Personal background and lifestyle IV

    Time frame: Baseline visit, 3, 6, 9, 12 months visit

    Assessment of personal background and lifestyle: sleep quality

  10. Medical History Assessment

    Time frame: Baseline visit, 3, 6, 9, 12 months visit

    Assessment of medical history:

    • pre-existing illnesses
    • current illnesses or allergies
    • chronic illnesses
    • medication
    • previous surgical procedures within the last 2 years
  11. Assessment of mental well-being using the Hospital Anxiety and Depression Scale - German Version (HADS-D) questionnaire

    Time frame: Baseline visit, 3, 6, 9, 12 months visit

    The questionnaire uses an anxiety scale and a depression scale (0-21, each). The higher the value, the more anxious/depressed the patient. Cut-off for clinical significance: ≥8

Sponsors and collaborators

Lead sponsor

VASCage GmbH

Other

Collaborators

  • Oroboros Instruments

Registry information

Official study title

Functional Mitochondrial Analysis of Peripheral Blood Mononuclear Cells (PBMCs) - a Pilot Study

Acronym: FMAP

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 12, 2024
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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