NCT06736249 HIF-1α Stabilization As a Novel Therapeutical Approach for Sarcopenia.
| NCT ID | NCT06736249 |
| Status | Recruiting |
| Phase | — |
| Sponsor | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio |
| Condition | Sarcopenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 105 participants |
| Start Date | 2023-05-25 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 105 participants in total. It began in 2023-05-25 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Laura Mangiavini
PRINCIPAL INVESTIGATOR
University of Milan, IRCCS Ospedale Galeazzi-Sant'Ambrogio
Frequently Asked Questions
Who can join the NCT06736249 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, up to 90 Years, studying Sarcopenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06736249 currently recruiting?
Yes, NCT06736249 is actively recruiting participants. Contact the research team at laura.mangiavini@unimi.it for enrollment information.
Where is the NCT06736249 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06736249 clinical trial?
NCT06736249 is sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio. The principal investigator is Laura Mangiavini at University of Milan, IRCCS Ospedale Galeazzi-Sant'Ambrogio. The trial plans to enroll 105 participants.