NCT02472340|Completed
Mitophagy and Autophagy in Elderly Subjects
Assessment and Reproducibility of Mitochondrial Function and Mitophagy Measurements in Human Muscle Tissue of Active and Pre Frail Elderly Males
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Assessment and Reproducibility of Mitochondrial Function and Mitophagy Measurements in Human Muscle Tissue of Active and Pre Frail Elderly Males
Sponsor study identifier
Secondary identifiers
OTHER · Amazentis
observational
22
1 country
1
Study Start
June 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2016
Actual (reported)Study Completion
July 2016
Actual (reported)In recent years, evidence has shown that mitochondrial dysfunction plays an important role in the development of age-related muscle decline that may lead to frailty. During aging, there is a progressive reduction in the cell's capacity to eliminate its dysfunctional elements by autophagy, as evidenced by the accumulation of oxidative damage and mutations in mitochondria and by the decrease in autophagic flux. In fact, it has been demonstrated that dysfunctional mitochondria can be specifically targeted for elimination by autophagy, a process that has been termed mitophagy. A major challenge in the clinic today is in the lack of validated tools, including biomarkers, to assess the decline in mitochondrial health associated with an impairment in muscle function. In the present study, the investigators will employ a battery of established and exploratory tests (clinical, physiological and molecular) to assess in vivo mitochondrial function and more specifically, the levels of mitophagy and autophagy, in the muscle of healthy and pre-frail elderly. It is anticipated that the results of this study will facilitate the rapid translation of interventions targeting mitophagy and autophagy for the improvement of muscle function.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2015
Date type not reportedThis date has not been verified as actual or estimated.
June 9, 2015
Actual (reported)June 15, 2015
Actual (reported)April 2016
Actual (reported)July 2016
Actual (reported)Gene and protein expression for autophagy and mitophagy biomarkers in muscle tissue
9 months
PCr recovery time (in seconds) measured by 31P-MRS (31-Phosphorus Magnetic Resonance Spectroscopy).
9 months
mVO2 (in ml/min/100 ml) in muscle measured by NIRS (Near-infrared Spectroscopy)
9 months
MitoPO2 (in mmHg) in the skin measured by PpIX-TSLT (Protoporphyrin IX - Triplet State Lifetime Technique).
9 months
Hand grip strength (in kg) measured by the Jamar dynamometer.
9 months
Peak muscle force of quadriceps measured by handheld dynamometry
9 months
Ratio of mtDNA to nuDNA in muscle
9 months
Gene and protein expression for mitophagy and autophagy in PBMC's
9 months
Skeletal muscle subtype via histology
9 months
10 sedentary, pre-frail elderly, \>61 year of age
10 Active, healthy elderly, \>61 years of age
Muscle Biopsy
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
* 10 active, healthy elderly, \>61 years of age * 10 sedentary, pre-frail elderly, \>61 years of age
Centre for Human Drug Research
Leiden, 2333, Netherlands
Muscle, Peripheral blood mononuclear cells (PBMC)
Geert Jan Groeneveld, MD, PhD
CHDR
Anurag Singh, MD, PhD
Amazentis SA
22 participants (actual enrollment reported by the registry).
First Submitted
June 9, 2015
First Posted
June 15, 2015
Study Start
June 2015
Date type not reportedThis date has not been verified as actual or estimated.
Composition & Function of Sarcoplasmic Reticulum in Persons With the Metabolic Syndrome
Contact the study team to confirm eligibility.
Primary Completion
April 2016
Actual (reported)Study Completion
July 2016
Actual (reported)Last Updated
August 1, 2016
Record last verified: 2016-03
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Source: ClinicalTrials.gov.
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