Functional Mitochondrial Analysis of Peripheral Blood Mononuclear Cells (PBMCs) - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- VASCage GmbH
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Stability of mitochondrial respiratory flux (O2 flux) in cryopreserved PBMCs
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 18-85
- •Willingness and ability to consent
排除标准
- •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
结局指标
主要结局
Stability of mitochondrial respiratory flux (O2 flux) in cryopreserved PBMCs
时间窗: 1 week and every 8 weeks after cryopreservation
Mitochondrial respiratory flux is assessed by High Resolution Respirometry analysis
Stability of O2 concentration in cryopreserved PBMCs
时间窗: 1 week and every 8 weeks after cryopreservation
Mitochondrial respiratory flux is assessed by High Resolution Respirometry analysis
Assessment of mitochondrial respiratory flux (O2 flux) in fresh PBMCs compared to cryopreserved PBMCs
时间窗: Baseline visit, 3, 6, 9, 12 months visit
Mitochondrial respiratory flux is assessed by High Resolution Respirometry analysis
Assessment of O2 concentration in fresh PBMCs compared to cryopreserved PBMCs
时间窗: Baseline visit, 3, 6, 9, 12 months visit
Mitochondrial respiratory flux is assessed by High Resolution Respirometry analysis
次要结局
- Concentration of HbA1c(Baseline, 6, 12 months visit)
- Concentration of triglyceride and cholesterol(Baseline, 6, 12 months visit)
- Assessment of Sedimentation rate(Baseline, 12 months visit)
- Assessment of O2 flux in fresh and cryopreserved PBMCs in fasted vs non-fasted sampling conditions(6 months visit)
- Assessment of blood count and differential blood count II(Baseline visit, 3, 6, 9, 12 months visit)
- Concentration of Creatinine and Urea(Baseline visit, 3, 6, 9, 12 months visit)
- Concentration of Thyroid-stimulating hormone(Baseline, 12 months visit)
- Concentration of Creatine Kinase(Baseline, 6, 12 months visit)
- Concentration of Sodium, Potassium, Chloride and Calcium(Baseline, 6, 12 months visit)
- Concentration of Lipoprotein a(Baseline visit)
- Assessment of blood count and differential blood count I(Baseline visit, 3, 6, 9, 12 months visit)
- Concentration of GOT and GPT(Baseline, 6, 12 months visit)
- Assessment of O2 flux in fresh and cryopreserved PBMCs at different seasonal collection time points(Baseline visit, 3, 6, 9, 12 months visit)
- Assessment of O2 flux in fresh and cryopreserved PBMCs at different venipuncture sites(3 months visit)
- Concentration of Glucose(Baseline visit, 3, 6, 9, 12 months visit)
- Concentration of LDL-cholesterol and HDL-cholesterol(Baseline, 6, 12 months visit)
- Concentration of C-reactive protein(Baseline visit, 3, 6, 9, 12 months visit)
- Concentration of Interleukin-6(Baseline, 6, 12 months visit)
- Concentration of Iric acid(Baseline, 12 months visit)
- Concentration of Ferritin(Baseline, 12 months visit)