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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorUniversity Hospital, Clermont-Ferrand

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Women weighing 170 kg or more

Inability to move around independently.

Participants with a spinal pathology.

Pregnant or breast-feeding women.

Trial design

Design model

Parallel

Treatments tested in this trial

  • maintaining mechanical load

    Other intervention

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Gravitostatic group (with mechanical load involving the use of a weighted vest)Experimental treatment 1 intervention
Group B: Non-gravitostatic group (control group)No intervention 0 interventions

Trial outcomes

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

Time frame
1 month and 3 months after bariatric surgery

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).

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

Time frame
6 months after bariatric surgery
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)

Other outcomes

Sponsors and contacts

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