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| Name | Class |
|---|---|
| Oroboros Instruments | UNKNOWN |
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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:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venipuncture | Other | Blood drawing | ||
| Questionnaire | Other | Completion of the questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| Stability of mitochondrial respiratory flux (O2 flux) in cryopreserved PBMCs | Mitochondrial respiratory flux is assessed by High Resolution Respirometry analysis | 1 week and every 8 weeks after cryopreservation |
| Stability of O2 concentration in cryopreserved PBMCs | Mitochondrial respiratory flux is assessed by High Resolution Respirometry analysis | 1 week and every 8 weeks after cryopreservation |
| Assessment of mitochondrial respiratory flux (O2 flux) in fresh PBMCs compared to cryopreserved PBMCs | Mitochondrial respiratory flux is assessed by High Resolution Respirometry analysis | Baseline visit, 3, 6, 9, 12 months visit |
| Assessment of O2 concentration in fresh PBMCs compared to cryopreserved PBMCs | Mitochondrial respiratory flux is assessed by High Resolution Respirometry analysis | Baseline visit, 3, 6, 9, 12 months visit |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of O2 flux in fresh and cryopreserved PBMCs in fasted vs non-fasted sampling conditions | Assessement of mitochondrial bioenergetic snapshot in fresh and cryopreserved PBMCs at two different collection time points (fasted and non-fasted) | 6 months visit |
| Assessment of O2 flux in fresh and cryopreserved PBMCs at different seasonal collection time points |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic data I | Assessment of demographic data such as current age, sex at birth, location of birth | Baseline visit |
| Demographic data II | Assessment of demographic data such as: height (cm) |
Inclusion Criteria:
Exclusion Criteria:
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The source population for this study comprises adults (older than 18 years of age) with an equal distribution of male and female.
Overall, 20 individuals will be included in the study (10 male, 10 female).
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| Name | Affiliation | Role |
|---|---|---|
| Michael Knoflach, AssozProf Dr | Medical University Innsbruck | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Innsbruck - Department of Neurology | Innsbruck | Tyrol | 6020 | Austria |
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| ID | Term |
|---|---|
| D018962 | Phlebotomy |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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Plasma
Assessement of mitochondrial bioenergetic snapshot in fresh and cryopreserved PBMCs in different seasons |
| Baseline visit, 3, 6, 9, 12 months visit |
| Assessment of O2 flux in fresh and cryopreserved PBMCs at different venipuncture sites | Assessement of mitochondrial bioenergetic snapshot in fresh and cryopreserved PBMCs collected from left and right arm | 3 months visit |
| Assessment of blood count and differential blood count I | Analysis of complete blood count (e.g. erythrocyte concentration (mg/dL)) | Baseline visit, 3, 6, 9, 12 months visit |
| Assessment of blood count and differential blood count II | Analysis of complete blood count (e.g. haemoglobin concentration (g/dL)) | Baseline visit, 3, 6, 9, 12 months visit |
| Concentration of Creatinine and Urea | Creatinine (mg/dL), Urea (mg/dL) | Baseline visit, 3, 6, 9, 12 months visit |
| Concentration of Creatine Kinase | Creatine Kinase (U/L) | Baseline, 6, 12 months visit |
| Concentration of Glucose | Glucose (mg/dL, mmol/L) | Baseline visit, 3, 6, 9, 12 months visit |
| Concentration of HbA1c | HbA1c (%) | Baseline, 6, 12 months visit |
| Concentration of Sodium, Potassium, Chloride and Calcium | Sodium (mmol/L), potassium (mmol/L), chloride (mmol/L), calcium (mmol/L) | Baseline, 6, 12 months visit |
| Concentration of GOT and GPT | Glutamic-oxaloacetic transaminase (GOT, U/L), glutamic-pyruvic transaminase (GPT, U/L), gamma-glutamyl-transpeptidase (gamma-GT, U/L), lactate dehydrogenase (LDH, U/L) | Baseline, 6, 12 months visit |
| Concentration of triglyceride and cholesterol | Triglyceride (mmol/L), cholesterol (all, mmol/L ) | Baseline, 6, 12 months visit |
| Concentration of LDL-cholesterol and HDL-cholesterol | LDL-cholesterol (mg/dL), HDL-cholesterol (mg/dL) | Baseline, 6, 12 months visit |
| Concentration of Lipoprotein a | Lipoprotein a (mg/dL) | Baseline visit |
| Assessment of Sedimentation rate | Sedimentation rate (mm/h) | Baseline, 12 months visit |
| Concentration of C-reactive protein | CRP sensitive (mg/L) | Baseline visit, 3, 6, 9, 12 months visit |
| Concentration of Interleukin-6 | Interleukin-6 (pg/ml) | Baseline, 6, 12 months visit |
| Concentration of Thyroid-stimulating hormone | TSH (mU/mL) | Baseline, 12 months visit |
| Concentration of Iric acid | Uric acid (mg/dL) | Baseline, 12 months visit |
| Concentration of Ferritin | Ferritin (ng/mL, μg/L) | Baseline, 12 months visit |
| Baseline visit |
| Demographic data III | Assessment of demographic data such as: weight (kg) | Baseline visit |
| Demographic data - Personal background and lifestyle I | Assessment of demographic data with focus on personal background and lifestyle: e.g.
| Baseline visit |
| Menstrual cycle duration (women only) | Assessment of menstrual cycle with focus on cycle duration (in days) | Baseline visit, 3, 6, 9, 12 months visit |
| Menstrual cycle length (women only) | Assessment of menstrual cycle with focus on the initiation of the last cycle (day) | Baseline visit, 3, 6, 9, 12 months visit |
| Demographic data - Personal background and lifestyle II | Assessment of demographic data with focus on personal background and lifestyle: smoking and smoking history, alcohol consumption and diet | Baseline visit, 3, 6, 9, 12 months visit |
| Demographic data - Personal background and lifestyle III | Assessment of demographic data with focus on personal background and lifestyle: amount and intensity of physical activity | Baseline visit, 3, 6, 9, 12 months visit |
| Demographic data - Personal background and lifestyle IV | Assessment of personal background and lifestyle: sleep quality | Baseline visit, 3, 6, 9, 12 months visit |
| Medical History Assessment | Assessment of medical history:
| Baseline visit, 3, 6, 9, 12 months visit |
| Assessment of mental well-being using the Hospital Anxiety and Depression Scale - German Version (HADS-D) questionnaire | 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 | Baseline visit, 3, 6, 9, 12 months visit |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |