New treatment approach for age-related muscle loss

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

This study is testing a new treatment that aims to help older adults with muscle loss by boosting a protein that encourages muscle growth, comparing their muscle health to that of younger people.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 105 (estimated)
• Ages: 65 Years to 90 Years
• Sex: All
• Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio (other)
• Locations: 1 site (Milan, Europe)
• Trial ID: NCT06736249 on ClinicalTrials.gov

What this trial studies

This study aims to explore a novel therapeutic approach for sarcopenia by activating hypoxia-inducible factor-1α (HIF-1α), which has been shown to promote muscle growth. The research will involve comparing muscle biopsies from sarcopenic patients to those from younger individuals to assess the effects of HIF-1α activation on muscle atrophy and regeneration. Participants will include both sarcopenic patients over 65 and non-sarcopenic individuals aged 18 to 35, with specific eligibility criteria related to joint health and metabolic conditions. The goal is to develop a treatment that can reduce disability in the elderly and alleviate healthcare costs associated with sarcopenia.

Who should consider this trial

Good fit: Ideal candidates include sarcopenic patients over 65 years old and non-sarcopenic individuals aged 18 to 35 with specific joint health conditions.

Not a fit: Patients with metabolic disorders affecting muscle health or those with certain infections or cancers may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve muscle health and mobility in elderly patients, reducing the risk of disability and falls.

How similar studies have performed: While the approach of activating HIF-1α is promising, it is relatively novel and has not been extensively tested in the context of sarcopenia.

Eligibility criteria

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

Where this trial is running

Milan, Europe

• IRCCS Ospedale Galeazzi-Sant'Ambrogio — Milan, Europe, Italy (RECRUITING)

Study contacts

• Principal investigator: Laura Mangiavini — University of Milan, IRCCS Ospedale Galeazzi-Sant'Ambrogio
• Study coordinator: Laura Mangiavini

Conditions: Sarcopenia