Obesity &Amp; OverweightGRAVITOSARCNCT07120685
Proof of Concept in the Prevention of Post-bariatric Sarcopenia: Simulated Activation of the "Gravitostat"
A study testing maintaining mechanical load in people with Obesity &Amp; Overweight and Bariatric Surgery, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Obesity &Amp; Overweight, Bariatric Surgery
- What is being tested?
- maintaining mechanical load
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2025to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU Clermont-Ferrand
Clermont-Ferrand
Yves BOIRIE, yboirie@chu-clermontferrand.fr
Yves BOIRIE
About this study
Official title: Proof of Concept in the Prevention of Post-bariatric Sarcopenia: Simulated Activation of the "Gravitostat", Randomized Pilot Study
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
- Being tested
- maintaining mechanical load
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maintaining mechanical loadOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Gravitostatic group (with mechanical load involving the use of a weighted vest) | Experimental | Not described Receives: Other: maintaining mechanical load |
| Non-gravitostatic group (control group) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
lean mass measurement with dual energy x-ray absorptiometry, DXA
Measured: 6 months after bariatric surgery
Change from baseline on weight at 1 month (M1), 3 months (M3), and 6 months (M6)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 1 month (M1), 3 months (M3), and 6 months (M6)
Muscle mass in the arms and legs at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery
Measured: 1 month (M1), 3 months (M3), and 6 months (M6)
Changes in muscle function (Handgrip strength test) at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery
Measured: 1 month (M1), 3 months (M3), and 6 months (M6)
Changes in muscle function (Short Physical Performance Battery (SPPB)) at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery
Measured: 1 month (M1), 3 months (M3), and 6 months (M6)
Changes in muscle function (6-minute walk test (TM6)) at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery
Measured: 1 month (M1), 3 months (M3), and 6 months (M6)
Changes from baseline on muscle architechture at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery
Analysis of muscle architecture and lipid infiltration using muscle ultrasound
Measured: 1 month (M1), 3 months (M3), and 6 months (M6)
Changes from baseline on bone architechture at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery
Analysis of bone mineral density (BMD) of trabecular and cortical bone compartments using peripheral quantitative computed tomography (PQCT)
Measured: 1 month (M1), 3 months (M3), and 6 months (M6)
Changes from baseline on bone architecture at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery
Analysis of bone strength of trabecular and cortical bone compartments using peripheral quantitative computed tomography (PQCT)
Measured: 1 month (M1), 3 months (M3), and 6 months (M6)
Changes from baseline on bone architecture at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery
Analysis of geometric parameters (volume, air) of trabecular and cortical bone compartments using peripheral quantitative computed tomography (PQCT)
Measured: 1 month (M1), 3 months (M3), and 6 months (M6)
Change from baseline on blood glucose at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery
Measured: 1 month (M1), 3 months (M3), and 6 months (M6)
Change from baseline on cholesterol at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery
Measured: 1 month (M1), 3 months (M3), and 6 months (M6)
Change from baseline on triglycerides at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery
Measured: 1 month (M1), 3 months (M3), and 6 months (M6)
Change from baseline on insulin levels at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery
Measured: 1 month (M1), 3 months (M3), and 6 months (M6)
Change from baseline on CRP at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery
Measured: 1 month (M1), 3 months (M3), and 6 months (M6)
Change from baseline on urinary creatinine at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery
Measured: 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 Plasma, serum, and urinary biomarkers
Biological collection
Measured: 1 month (M1), 3 months (M3), and 6 months (M6)
Effect on Maximal strength
Effect of weight compensation at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery on maximum strenght (isokinetic dynamometry)
Measured: 1 month (M1), 3 months (M3), and 6 months (M6)
Effect on Food intake
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)
Measured: 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 Nitrogen balance
Measured: 1 month (M1), 3 months (M3), and 6 months (M6)
Effect on Quality of life using a visual analog scale
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
Measured: 1 month (M1), 3 months (M3), and 6 months (M6)
Effect on Food preferences and reward
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)
Measured: 1 month (M1), 3 months (M3), and 6 months (M6)
To assess the effect of weight compensation at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery on energy expenditure
Energy expenditure (resting and total)
Measured: 1 month (M1), 3 months (M3), and 6 months (M6)
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
Evaluate the use of energy substrates through the oxidation of carbohydrates and lipids an incremental submaximal walking exercise using in indirect calorimetry.
Measured: 1 month (M1), 3 months (M3), and 6 months (M6)
Effect on perceived exertion during an exercise (Borg scale)
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
Measured: 1 month (M1), 3 months (M3), and 6 months (M6)
Effect of heart rate
During an incremental submaximal walking exercise
Measured: 1 month (M1), 3 months (M3), and 6 months (M6)
Effect of weight compensation on spontaneous physical activity using accelerometry
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.
Measured: on day 4 or the day after returning home following surgery, and then at 1 month (M1) and 3 months (M3) after surgery.
Study the longitudinal evolution of weight every week until M1, then every 2 weeks until M3 for the experimental group.
Measured: every week until 1st month, then every 2 weeks until 3rd month after bariatric surgery
Study the longitudinal evolution of BMI every week until M1, then every 2 weeks until M3 for the experimental group.
Measured: every week until 1st month, then every 2 weeks until 3rd month after bariatric surgery
Tolerance with wearing the vest for the experimental group
Tolerance with wearing the vest for the experimental group, using a patient diary.
Measured: from bariatric surgery to the end at 3 months
Compliance with wearing the vest for the experimental group
Compliance with wearing the vest for the experimental group, using a patient diary.
Measured: from bariatric surgery to the end at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Obesity &Amp; OverweightStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves BOIRIE, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120685
- Sponsor's protocol ID
- AOI 2023 BOIRIE
- Acronym
- GRAVITOSARC
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19834464Thivel 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.
PubMed 33033796Ohlsson 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.
PubMed 29800288Jansson 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.
PubMed 29279372
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept in the Prevention of Post-bariatric Sarcopenia: Simulated Activation of the "Gravitostat", Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT07120685
- Acronym / sponsor ID
- GRAVITOSARC / AOI 2023 BOIRIE
- Conditions
- Obesity &Amp; Overweight, Bariatric Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gravitostatic group (with mechanical load involving the use of a weighted vest) | Experimental | Other: maintaining mechanical load |
| Non-gravitostatic group (control group) | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| maintaining mechanical loadThe 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. | Other | Gravitostatic group (with mechanical load involving the use of a weighted vest) |
Primary outcome
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
34 secondary outcomes
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Effect on Maximal strength
Time frame: 1 month (M1), 3 months (M3), and 6 months (M6)
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 Nitrogen balance
Time frame: 1 month (M1), 3 months (M3), and 6 months (M6)
Effect on Quality of life using a visual analog scale
Time frame: 1 month (M1), 3 months (M3), and 6 months (M6)
Effect on Food preferences and reward
Time frame: 1 month (M1), 3 months (M3), and 6 months (M6)
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)
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)
Effect on perceived exertion during an exercise (Borg scale)
Time frame: 1 month (M1), 3 months (M3), and 6 months (M6)
Effect of heart rate
Time frame: 1 month (M1), 3 months (M3), and 6 months (M6)
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.
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
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
Tolerance 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
Time frame: from bariatric surgery to the end at 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Background: PubMed 19834464Ciangura 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.
- Background: PubMed 33033796Thivel 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.
- Background: PubMed 29800288Ohlsson 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.
- Background: PubMed 29279372Jansson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yves BOIRIE principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing maintaining mechanical load in people with Obesity &Amp; Overweight and Bariatric Surgery, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07120685, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.