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

NCT ID: NCT07120685

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2027-11-30

Brief Summary

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.

Conditions

Obesity &Amp; Overweight; Bariatric Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

maintaining mechanical load

Intervention Type: OTHER

The method for maintaining mechanical load (artificially reproducing the stabilization of initial body weight) will involve the use of a weighted vest.

Participants will be asked to wear the weighted vest for at least eight hours a day over a four-week period without changing their lifestyle. Patients will also be contacted by phone every week after surgery to confirm that they are using the vest in accordance with the protocol and to collect information on any potential adverse events. During these calls, weight adjustments-based on body weight changes-will be discussed with the patient and regularly recorded to stay as close as possible to the initial body weight, with a tolerance of ±1 kg. However, the maximum weight of the vest will not exceed 15% of the patient's initial weight (weight at the time of surgery).

Between the 4th and 12th week, patients will be asked to wear the weighted vest loaded with the "weight lost" calculated at week 4 for at least four hours per day.

Non-gravitostatic group (control group)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

maintaining mechanical load

The method for maintaining mechanical load (artificially reproducing the stabilization of initial body weight) will involve the use of a weighted vest.

Participants will be asked to wear the weighted vest for at least eight hours a day over a four-week period without changing their lifestyle. Patients will also be contacted by phone every week after surgery to confirm that they are using the vest in accordance with the protocol and to collect information on any potential adverse events. During these calls, weight adjustments-based on body weight changes-will be discussed with the patient and regularly recorded to stay as close as possible to the initial body weight, with a tolerance of ±1 kg. However, the maximum weight of the vest will not exceed 15% of the patient's initial weight (weight at the time of surgery).

Between the 4th and 12th week, patients will be asked to wear the weighted vest loaded with the "weight lost" calculated at week 4 for at least four hours per day.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yves BOIRIE

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU Clermont-Ferrand

Clermont-Ferrand, , France

Countries

France

Central Contacts

Lise Laclautre

Role: CONTACT

promo_interne_drci@chu-clermontferrand.fr

334.73.754.963

Facility Contacts

Yves BOIRIE

Role: primary

yboirie@chu-clermontferrand.fr

References

Ciangura C, Bouillot JL, Lloret-Linares C, Poitou C, Veyrie N, Basdevant A, Oppert JM. Dynamics of change in total and regional body composition after gastric bypass in obese patients. Obesity (Silver Spring). 2010 Apr;18(4):760-5. doi: 10.1038/oby.2009.348. Epub 2009 Oct 15.

Reference Type: BACKGROUND

PMID: 19834464 (View on PubMed)

Thivel D, Boirie Y. The Gravitostat theory: Body fat is lost but is fat-free mass preserved? EClinicalMedicine. 2020 Oct 3;27:100531. doi: 10.1016/j.eclinm.2020.100531. eCollection 2020 Oct. No abstract available.

Reference Type: BACKGROUND

PMID: 33033796 (View on PubMed)

Ohlsson C, Hagg DA, Hammarhjelm F, Dalmau Gasull A, Bellman J, Windahl SH, Palsdottir V, Jansson JO. The Gravitostat Regulates Fat Mass in Obese Male Mice While Leptin Regulates Fat Mass in Lean Male Mice. Endocrinology. 2018 Jul 1;159(7):2676-2682. doi: 10.1210/en.2018-00307.

Reference Type: BACKGROUND

PMID: 29800288 (View on PubMed)

Jansson JO, Palsdottir V, Hagg DA, Schele E, Dickson SL, Anesten F, Bake T, Montelius M, Bellman J, Johansson ME, Cone RD, Drucker DJ, Wu J, Aleksic B, Tornqvist AE, Sjogren K, Gustafsson JA, Windahl SH, Ohlsson C. Body weight homeostat that regulates fat mass independently of leptin in rats and mice. Proc Natl Acad Sci U S A. 2018 Jan 9;115(2):427-432. doi: 10.1073/pnas.1715687114. Epub 2017 Dec 26.

Reference Type: BACKGROUND

PMID: 29279372 (View on PubMed)

Other Identifiers

AOI 2023 BOIRIE

Identifier Type: -

Identifier Source: org_study_id