New treatment approach for age-related muscle loss
Official title: Attivazione Farmacologica Di HIF-1α Come Nuovo Approccio Terapeutico Per Contrastare La Perdita Di Fibre Glicolitiche in Pazienti Sarcopenici.
Run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · NCT06736249 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 65 Years to 90 Years |
| Sex | All |
| Enrollment | 105 (estimated) |
| Sponsor | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio Academic / other |
| Locations | 1 site (Milan, Europe) |
| Status | Recruiting |
| Started | May 25, 2023 |
| Main results expected | June 2025 |
| Study ends | January 2026 |
| Registry record updated | December 16, 2024 |
| Trial ID | NCT06736249 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include sarcopenic patients over 65 years old and non-sarcopenic individuals aged 18 to 35 with specific joint health conditions.
✕Probably not a fit
Patients with metabolic disorders affecting muscle health or those with certain infections or cancers may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While the approach of activating HIF-1α is promising, it is relatively novel and has not been extensively tested in the context of sarcopenia.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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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
- Email: laura.mangiavini@unimi.it
- Phone: 0283506790
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This study tests whether a multimodal ultrasound approach can accurately measure muscle mass in people with metabolic syndrome, obesity, sarcopenia, or type 2 diabetes.
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In adults aged 60 and older with sarcopenia, this study tests whether adding robot-assisted leg training to nutrition education can improve muscle mass and walking ability compared with usual care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.