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

NCT07120685 | Not Yet Recruiting

• 1 other identifier: AOI 2023 BOIRIE
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Loss of lean mass at 1 monts and 3 months after bariatric surgery in patients undergoing "weight compensation" compared to a group of patients following a conventional approach (without gravitostat activation).

  lean mass measurement with dual energy x-ray absorptiometry, DXA

  1 month and 3 months after bariatric surgery

Secondary Outcomes (34)

• Loss of lean mass at 6 months after bariatric surgery in patients undergoing "weight compensation" compared to a group of patients following a conventional approach (without gravitostat activation).

  6 months after bariatric surgery

• Change from baseline on weight at 1 month (M1), 3 months (M3), and 6 months (M6)

  1 month (M1), 3 months (M3), and 6 months (M6)

• Change from baseline on BMI at 1 month (M1), 3 months (M3), and 6 months (M6)

  1 month (M1), 3 months (M3), and 6 months (M6)

• Change from baseline on waist circumference at 1 month (M1), 3 months (M3), and 6 months (M6)

  1 month (M1), 3 months (M3), and 6 months (M6)

• Change from baseline on hip circumference at 1 month (M1), 3 months (M3), and 6 months (M6)

  1 month (M1), 3 months (M3), and 6 months (M6)

Study Arms (2)

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

EXPERIMENTAL

Other: maintaining mechanical load

Non-gravitostatic group (control group)

NO INTERVENTION

Interventions

maintaining mechanical load 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.

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

Related Publications (4)

• 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.

  PMID: 19834464 BACKGROUND

• 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.

  PMID: 33033796 BACKGROUND

• 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.

  PMID: 29800288 BACKGROUND

• 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.

  PMID: 29279372 BACKGROUND

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yves BOIRIE

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: August 13, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: August 13, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)