Medical University Innsbruck - Department of Neurology
Innsbruck, Tyrol, 6020, Austria
NCT Number: NCT06498791
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–85 year
All sexes
Observational
Innsbruck, Tyrol, 6020, Austria
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Blood drawing
Completion of the questionnaire
Time frame: 1 week and every 8 weeks after cryopreservation
Mitochondrial respiratory flux is assessed by High Resolution Respirometry analysis
Time frame: 1 week and every 8 weeks after cryopreservation
Mitochondrial respiratory flux is assessed by High Resolution Respirometry analysis
Time frame: Baseline visit, 3, 6, 9, 12 months visit
Mitochondrial respiratory flux is assessed by High Resolution Respirometry analysis
Time frame: Baseline visit, 3, 6, 9, 12 months visit
Mitochondrial respiratory flux is assessed by High Resolution Respirometry analysis
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)
Time frame: Baseline visit, 3, 6, 9, 12 months visit
Assessement of mitochondrial bioenergetic snapshot in fresh and cryopreserved PBMCs in different seasons
Time frame: 3 months visit
Assessement of mitochondrial bioenergetic snapshot in fresh and cryopreserved PBMCs collected from left and right arm
Time frame: Baseline visit, 3, 6, 9, 12 months visit
Analysis of complete blood count (e.g. erythrocyte concentration (mg/dL))
Time frame: Baseline visit, 3, 6, 9, 12 months visit
Analysis of complete blood count (e.g. haemoglobin concentration (g/dL))
Time frame: Baseline visit, 3, 6, 9, 12 months visit
Creatinine (mg/dL), Urea (mg/dL)
Time frame: Baseline, 6, 12 months visit
Creatine Kinase (U/L)
Time frame: Baseline visit, 3, 6, 9, 12 months visit
Glucose (mg/dL, mmol/L)
Time frame: Baseline, 6, 12 months visit
HbA1c (%)
Time frame: Baseline, 6, 12 months visit
Sodium (mmol/L), potassium (mmol/L), chloride (mmol/L), calcium (mmol/L)
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)
Time frame: Baseline, 6, 12 months visit
Triglyceride (mmol/L), cholesterol (all, mmol/L )
Time frame: Baseline, 6, 12 months visit
LDL-cholesterol (mg/dL), HDL-cholesterol (mg/dL)
Time frame: Baseline visit
Lipoprotein a (mg/dL)
Time frame: Baseline, 12 months visit
Sedimentation rate (mm/h)
Time frame: Baseline visit, 3, 6, 9, 12 months visit
CRP sensitive (mg/L)
Time frame: Baseline, 6, 12 months visit
Interleukin-6 (pg/ml)
Time frame: Baseline, 12 months visit
TSH (mU/mL)
Time frame: Baseline, 12 months visit
Uric acid (mg/dL)
Time frame: Baseline, 12 months visit
Ferritin (ng/mL, μg/L)
Time frame: Baseline visit
Assessment of demographic data such as current age, sex at birth, location of birth
Time frame: Baseline visit
Assessment of demographic data such as: height (cm)
Time frame: Baseline visit
Assessment of demographic data such as: weight (kg)
Time frame: Baseline visit
Assessment of demographic data with focus on personal background and lifestyle: e.g.
Time frame: Baseline visit, 3, 6, 9, 12 months visit
Assessment of menstrual cycle with focus on cycle duration (in days)
Time frame: Baseline visit, 3, 6, 9, 12 months visit
Assessment of menstrual cycle with focus on the initiation of the last cycle (day)
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
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
Time frame: Baseline visit, 3, 6, 9, 12 months visit
Assessment of personal background and lifestyle: sleep quality
Time frame: Baseline visit, 3, 6, 9, 12 months visit
Assessment of medical history:
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
VASCage GmbH
Other
Functional Mitochondrial Analysis of Peripheral Blood Mononuclear Cells (PBMCs) - a Pilot Study
Acronym: FMAP
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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