Proof of Concept in the Prevention of Post-bariatric Sarcopenia: Simulated Activation of the "Gravitostat" (GRAVITOSARC)

University Hospital, Clermont-Ferrand

Status: Not yet enrolling

Conditions: Obesity &Amp; Overweight; Bariatric Surgery

Treatments: Other: maintaining mechanical load

Study type: Interventional

Funder types: Other

Identifiers

NCT07120685

AOI 2023 BOIRIE

Details and patient eligibility

About

Due to its mechanical and metabolic functions, muscle loss leads to resistance to weight loss during caloric restriction, particularly in patients with obesity. The recent discovery of a "gravitational" homeostatic system, induced by an additional load to body weight, suggests the existence of a new weight control mechanism. Such a "gravitostat" would ensure a form of weight homeostasis mediated by afferent signals originating from osteocytes in response to gravity perception. This hypothesis, initially derived from animal studies, has more recently been tested in humans. It shows that "activation of the gravitostat" through artificial increases in body weight facilitates body weight reduction without affecting lean mass (LM). Therefore, this "gravitostat" could contribute to preserving LM despite the loss of fat mass , whereas its decline may compromise muscle mass and function after bariatric surgery, despite undeniable improvements in comorbidities.

The present study aims to reduce the "metabolic load" (i.e., decreasing insulin resistance and inflammation) to promote muscle protein anabolism, while maintaining the "mechanical load" (by preserving initial body weight during weight loss induced by bariatric surgery) in order to activate the "gravitostat" and preserve muscle mass and function.

Currently, there are no clear recommendations or strategies to prevent muscle loss in patients who have undergone bariatric surgery. This simple concept, applied during drastic muscle loss, should help improve muscle health.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female participants
• Aged between 18 and 60 years
• Planned for bariatric surgery, such as sleeve gastrectomy
• Able to give informed consent to participate in research
• Affiliated to a social security scheme

Exclusion criteria

• Women weighing 170 kg or more
• Inability to move around independently.
• Participants with a spinal pathology.
• Pregnant or breast-feeding women.
• Inability to comply with protocol recommendations.
• Adults under legal guardianship (curatorship, guardianship, deprivation of liberty, patients benefiting from a judicial protection measure or safeguard of justice).
• Refusal to participate.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Gravitostatic group (with mechanical load involving the use of a weighted vest)

Experimental group

Treatment:

Other: maintaining mechanical load

Non-gravitostatic group (control group)

No Intervention group