Functional Mitochondrial Analysis PBMCs
NCT Number: NCT06498791
Acronym: FMAP
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Mitochondrial Function
Interventions: OTHER: Venipuncture|OTHER: Questionnaire
Sponsor: VASCage GmbH
Collaborators: Oroboros Instruments
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2026-05

Summary:
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.

Primary Outcome Measures: 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
Secondary Outcome Measures: 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, 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
Other Outcome Measures: 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), 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.

* ethnicity (anamnesis)
* marital/relationship status (anamnesis)
* number of children (anamnesis)
* highest level of education (anamnesis), 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:

* pre-existing illnesses
* current illnesses or allergies
* chronic illnesses
* medication
* previous surgical procedures within the last 2 years, 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