Ignite Creation Date:
2024-07-17 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06498791
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-06-18
Brief Title:
Functional Mitochondrial Analysis PBMCs
Sponsor:
VASCage GmbH
Organization:
VASCage GmbH
Study Overview
Official Title:
Functional Mitochondrial Analysis of Peripheral Blood Mononuclear Cells PBMCs - A Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FMAP
Brief 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
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
Detailed Description:
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 individuals 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None