Mitophagy and Autophagy in Elderly Subjects (NCT02472340) | Clinical Trial Compass
CompletedNot Applicable
Mitophagy and Autophagy in Elderly Subjects
Netherlands22 participantsStarted 2015-06
Plain-language summary
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.
Who can participate
Age range
61 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. \>61 years of age, inclusive.
. Healthy male subjects. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, haematology, blood chemistry, and urinalysis.
. Body mass index (BMI) between 15 and 32 kg/m2, inclusive.
. Able to participate and willing to give written informed consent and to comply with the study restrictions.
. Category 2 or 3 as assessed by the International Physical Activity Questionnaires (IPAQ). Activity level is ≥ 600 MET (metabolic equivalent unit) - minutes per week.
. Normal physical performance: normal gait speed, i.e. a walking ≥ 0.8 m/s in the 4-m walking test.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Gene and protein expression for autophagy and mitophagy biomarkers in muscle tissue
. Normal muscle mass: normal skeletal muscle mass index (SMI), measured by Bioimpedance analysis (BIA, ≥ 10.75 kg/m2).
. Normal muscle strength: handgrip strength (measured with the Jamar dynamometer) of ≥ 30 kg.
Exclusion criteria
. Presence of any contraindication to have MRI scans performed (e.g. pacemaker, intracranial clips etc.).
. Having diabetes mellitus or lower extremity peripheral vascular disease, as these conditions may interfere with interpretation of the dynamic 31P-MRS and NIRS of the lower extremity.
. Participation in a clinical trial within 90 days of screening or more than 4 times in the previous year.
. A history (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol).
. Smoking within 3 months prior to screening and inability to refrain from smoking during the course of the study (from screening to End-of-Study \[EOS\]).
. A history or presence of allergy to 5-aminolevulinic acid or porphyrins.
. A history or presence of allergy to lidocaine.
. Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening.