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NCT Number: NCT07120685

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

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.

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Key information

Conditions

Obesity &Amp; Overweight Bariatric Surgery Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location contact

Yves BOIRIE

CONTACT

[email protected]

Yves BOIRIE

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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).

    Time frame: 1 month and 3 months after bariatric surgery

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

Secondary outcomes

  1. 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).

    Time frame: 6 months after bariatric surgery

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

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

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

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

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

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

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

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

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

  6. Muscle mass in the arms and legs at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery

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

  7. Changes in muscle function (Handgrip strength test) at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery

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

  8. Changes in muscle function (Short Physical Performance Battery (SPPB)) at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery

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

  9. Changes in muscle function (6-minute walk test (TM6)) at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery

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

  10. Changes from baseline on muscle architechture at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery

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

    Analysis of muscle architecture and lipid infiltration using muscle ultrasound

  11. Changes from baseline on bone architechture at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery

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

    Analysis of bone mineral density (BMD) of trabecular and cortical bone compartments using peripheral quantitative computed tomography (PQCT)

  12. Changes from baseline on bone architecture at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery

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

    Analysis of bone strength of trabecular and cortical bone compartments using peripheral quantitative computed tomography (PQCT)

  13. Changes from baseline on bone architecture at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery

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

    Analysis of geometric parameters (volume, air) of trabecular and cortical bone compartments using peripheral quantitative computed tomography (PQCT)

  14. Change from baseline on blood glucose at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery

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

  15. Change from baseline on cholesterol at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery

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

  16. Change from baseline on triglycerides at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery

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

  17. Change from baseline on insulin levels at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery

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

  18. Change from baseline on CRP at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery

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

  19. Change from baseline on urinary creatinine at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery

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

  20. Effect of weight compensation at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery on Plasma, serum, and urinary biomarkers

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

    Biological collection

  21. Effect on Maximal strength

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

    Effect of weight compensation at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery on maximum strenght (isokinetic dynamometry)

  22. Effect on Food intake

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

    Effect of weight compensation at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery on Food intake (nutrient intake using the "Nutrilog" software)

  23. Effect of weight compensation at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery on Nitrogen balance

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

  24. Effect on Quality of life using a visual analog scale

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

    Effect of weight compensation at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery on Quality of life using a visual analog scale

  25. Effect on Food preferences and reward

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

    Effect of weight compensation at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery on Food preferences and reward by using LFPQ (Leeds Food Preference Questionnaire)

  26. To assess the effect of weight compensation at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery on energy expenditure

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

    Energy expenditure (resting and total)

  27. Effect on substrate utilization during an incremental submaximal walking exercise at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery on energy expenditure

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

    Evaluate the use of energy substrates through the oxidation of carbohydrates and lipids an incremental submaximal walking exercise using in indirect calorimetry.

  28. Effect on perceived exertion during an exercise (Borg scale)

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

    Effect of weight compensation at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery on perceived exertion during an incremental submaximal walking exercise

  29. Effect of heart rate

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

    During an incremental submaximal walking exercise

  30. Effect of weight compensation on spontaneous physical activity using accelerometry

    Time frame: on day 4 or the day after returning home following surgery, and then at 1 month (M1) and 3 months (M3) after surgery.

    Effect of weight compensation on spontaneous physical activity (sedentary, low, moderate and intense) per day (min/d) at baseline, on day 4 or the day after returning home following surgery, and then at 1 month (M1) and 3 months (M3) after surgery.

  31. Study the longitudinal evolution of weight every week until M1, then every 2 weeks until M3 for the experimental group.

    Time frame: every week until 1st month, then every 2 weeks until 3rd month after bariatric surgery

  32. Study the longitudinal evolution of BMI every week until M1, then every 2 weeks until M3 for the experimental group.

    Time frame: every week until 1st month, then every 2 weeks until 3rd month after bariatric surgery

  33. Tolerance with wearing the vest for the experimental group

    Time frame: from bariatric surgery to the end at 3 months

    Tolerance with wearing the vest for the experimental group, using a patient diary.

  34. Compliance with wearing the vest for the experimental group

    Time frame: from bariatric surgery to the end at 3 months

    Compliance with wearing the vest for the experimental group, using a patient diary.

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Laclautre

CONTACT

[email protected]

334.73.754.963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

Proof of Concept in the Prevention of Post-bariatric Sarcopenia: Simulated Activation of the "Gravitostat", Randomized Pilot Study

Acronym: GRAVITOSARC

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 13, 2025
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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