RecruitingNot ApplicableNCT06736249

HIF-1α Stabilization As a Novel Therapeutical Approach for Sarcopenia.

Attivazione Farmacologica Di HIF-1α Come Nuovo Approccio Terapeutico Per Contrastare La Perdita Di Fibre Glicolitiche in Pazienti Sarcopenici.


Sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Enrollment

105 participants

Start Date

May 25, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 65 YearsMax Age: 90 Years

Inclusion Criteria9

  • For non-sarcopenic patients aged 18 to 35 years, for sarcopenic patients aged > 65 years.
  • ≤ body mass index (BMI) ≤ 30 kg/m2.
  • For the sarcopenic group:
  • non-inflammatory degenerative joint disease, including osteoarthritis and outcomes of congenital hip dysplasia.
  • surgeries to correct hip joint deformities
  • fractures of the proximal femur involving the head that cannot be treated with reduction and fixation techniques
  • hip revision surgery.
  • For the non-sarcopenic group:
  • \. traumatic injury to the anterior cruciate ligament.

Exclusion Criteria9

  • 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

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Interventions

DIAGNOSTIC_TESTSarcopenic group

The sarcopenic group will undergo a DXA total body to define the sarcopenic stage.

OTHERMuscle harvesting

A piece of discarded muscle during surgery will be collected


Locations(1)

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, Europe, Italy

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NCT06736249


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