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

NCT06736249 | Recruiting

• 1 other identifier: HIF2
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

• To evaluate that the pharmacological activation of HIF-1alpha is an effective approach to counteract sarcopenia.

  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.

  18 months

Secondary Outcomes (2)

• To perform a proteome analysis on the samples

  12 months

• To evaluate metabolic differences between sarcopenic and control goups

  12 months

Study Arms (2)

Sarcopenic group

EXPERIMENTAL

This group will undergo a DXA total body to confirm sarcopenia

Diagnostic Test: Sarcopenic group; Other: Muscle harvesting

Control

OTHER

This group is a control group of young active patients to compare with the sarcopenic group

Other: Muscle harvesting

Interventions

Sarcopenic group DIAGNOSTIC_TEST

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

Sarcopenic group

Muscle harvesting OTHER

A piece of discarded muscle during surgery will be collected

Control; Sarcopenic group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, Europe, 20157, Italy

RECRUITING

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Laura Mangiavini

  University of Milan, IRCCS Ospedale Galeazzi-Sant'Ambrogio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Mangiavini

CONTACT

0283506790; laura.mangiavini@unimi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: December 16, 2024
• Study Start: May 25, 2023
• Primary Completion: June 1, 2025
• Study Completion: January 1, 2026
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)