Bariatric Surgery, Obesity &Amp; Overweight
Conditions
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.
Interventions
OTHERmaintaining 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.
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 1 month and 3 months after bariatric surgery | lean mass measurement with dual energy x-ray absorptiometry, DXA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | lean mass measurement with dual energy x-ray absorptiometry, DXA |
| 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) | — |
| Muscle mass in the arms and legs at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery | 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 | 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 | 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 | 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 | 1 month (M1), 3 months (M3), and 6 months (M6) | Analysis of muscle architecture and lipid infiltration using muscle ultrasound |
| Changes from baseline on bone architechture at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery | 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) |
| Changes from baseline on bone architecture at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery | 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) |
| Change from baseline on blood glucose at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery | 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 | 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 | 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 | 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 | 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 | 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 | 1 month (M1), 3 months (M3), and 6 months (M6) | Biological collection |
| Effect on Maximal strength | 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) |
| Effect on Food intake | 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) |
| Effect on Quality of life using a visual analog scale | 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 |
| Effect on Food preferences and reward | 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) |
| To assess the effect of weight compensation at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery on energy expenditure | 1 month (M1), 3 months (M3), and 6 months (M6) | Energy expenditure (resting and total) |
| 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 | 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. |
| Effect on perceived exertion during an exercise (Borg scale) | 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 |
| Effect of heart rate | 1 month (M1), 3 months (M3), and 6 months (M6) | During an incremental submaximal walking exercise |
| Effect of weight compensation on spontaneous physical activity using accelerometry | 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. |
| Study the longitudinal evolution of weight every week until M1, then every 2 weeks until M3 for the experimental group. | 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. | every week until 1st month, then every 2 weeks until 3rd month after bariatric surgery | — |
| Tolerance with wearing the vest for the experimental group | from bariatric surgery to the end at 3 months | Tolerance with wearing the vest for the experimental group, using a patient diary. |
| Compliance with wearing the vest for the experimental group | from bariatric surgery to the end at 3 months | Compliance with wearing the vest for the experimental group, using a patient diary. |
| Change from baseline on CRP at 1 month (M1), 3 months (M3), and 6 months (M6) after surgery | 1 month (M1), 3 months (M3), and 6 months (M6) | — |
Countries
France
Contacts
Primary ContactLise Laclautre
Outcome results
None listed