Mitochondrial Dysfunction clinical trials

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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NCT ID: NCT06433427 Not yet recruiting - Aging Clinical Trials

Metabolic Dysregulation as Biomarker of Frailty: Role of the Mitochondrial Dysfunction

FRAMITO

Start date: May 29, 2024
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to evaluate the presence of mitochondrial dysfunction related to oxidative stress and its possible role in frailty, with and without multimorbidity, and to identify possible frailty biomarkers correlated with mitochondrial dysfunction. The main questions it aims to answer are: - What is the role of oxidative stress-related mitochondrial dysfunction in frailty, taking into account the interaction with multimorbidity. - What could be the specific biomarkers associated with mitochondrial dysfunction in the assessment of frailty. In order to reach the study goals, we will enroll three categories of older adults: - Non-Frail without Multimorbidity (NFWoM); - Frail with Multimorbidity (FWM); - Frail without Multimorbidity (FWoM). Each individual will undergo an assessment of frailty phenotype and multimorbidity, and the collection of blood samples to isolate Peripheral Blood Mononuclear Cells (PBMCs). The identification of frailty biomarkers in each group of participants will be performed by combining untargeted metabolomics-based approaches and functional studies on specific mitochondrial dysfunctions performed on PBMCs and their subpopulations. Multivariate statistical and machine learning techniques will characterize the three clinical phenotype groups based on molecular data.