Sarcopenic group: The sarcopenic group will undergo a DXA total body to define the sarcopenic stage.
Muscle harvesting: A piece of discarded muscle during surgery will be collected
Study summary
Age-related sarcopenia is associated with reduced mobility, functional decline and disability, falls, and mortality in the elderly. Loss of skeletal muscle is the focus of the disease and is the result of progressive atrophy and loss of glycolytic-type muscle fibers. Muscle mass declines at a rate of 3-5% per decade after thirty years, and the decrease accelerates further after sixty years (Patel et al., 2013). As life expectancy increases worldwide, it is clear that sarcopenia is considered a major contributor to healthcare costs and that even a small reduction in the prevalence of sarcopenia could result in substantial savings in healthcare resources (Goates et al., 2019). In this context, the present proposal aims to develop a new therapeutic approach based on the activation of HIF-1alpha, which has been shown to promote skeletal muscle hypertrophy, to prevent and counteract sarcopenia, thereby reducing disability in the elderly and the impact on the national health care system.
Eligibility
Sex
ALL
Min age
65 Years
Max age
90 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* For non-sarcopenic patients aged 18 to 35 years, for sarcopenic patients aged \> 65 years.
* 18 ≤ body mass index (BMI) ≤ 30 kg/m2.
* For the sarcopenic group:
1. non-inflammatory degenerative joint disease, including osteoarthritis and outcomes of congenital hip dysplasia.
2. surgeries to correct hip joint deformities
3. fractures of the proximal femur involving the head that cannot be treated with reduction and fixation techniques
4. hip revision surgery.
* For the non-sarcopenic group:
5\. traumatic injury to the anterior cruciate ligament.
Exclusion Criteria:
* Use of medications that may affect metabolism or bone,
* Signs of diseases known to affect muscle-bone metabolism.
* Bone metastases or disease at the surgical site.
* Positive for HCV, HIV, HBV, or TPHA.
* Presence of infection or suspected hip infection.
* Inability to provide informed consent.
* Obesity (BMI ≥30kg/m2).
* Inability to undergo DXA total body in sarcopenic patients due to medical contraindications or claustrophobia.
For sarcopenic group: ASMI \>7.0 kg/m2 form men and \>5.5 kg/m2 for women; FMI \<6 for men and \<9 for women For control group: pregnancy or breastfeeding
Primary outcome measure(s)
To evaluate that the pharmacological activation of HIF-1alpha is an effective approach to counteract sarcopenia. — 18 months Satellite cells harvested from sarcopenic patients will be treated with FG-4592, a PHD inhibitor.At the end of the treatment, metabolic changes will be analyzed using Seahorse Real-Time Cell Metabolic Analysis.
Trial sites (1)
Facility
City
Region
Status
IRCCS Ospedale Galeazzi-Sant'Ambrogio
Milan
Europe
Recruiting
More I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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