Diet, HealthyObesity, VisceralBariatric Surgery Candidate
Investigational drug(s) / intervention(s)
With low-calorie, high-protein dietWithout low-calorie, high-protein diet
With low-calorie, high-protein diet: A low-calorie, high-protein diet will be prescribed to the patient for a period of 4 weeks. The diet will be done the 4 weeks before the bariatric surgery
Without low-calorie, high-protein diet: A low-calorie, high-protein diet will not be prescribed to the patient for a period of 4 weeks.
Study summary
Obesity is a major public health problem and is constantly on the rise. Therapeutic approaches based on dietary advice, physical activity and the management of psychological difficulties are not always sufficient to achieve a lasting weight reduction.
Bariatric surgery (or obesity surgery), accompanied by therapeutic education and adequate medical and dietary monitoring, can lead to significant and lasting weight loss. It is indicated as a second-line treatment for patients who have failed medical treatment, whose BMI is greater than or equal to 40 or whose BMI is greater than or equal to 35 with comorbidities (type 2 diabetes, arterial hypertension, obstructive sleep apnoea-hypopnoea syndrome, severe joint disorders).
The surgeon may be very bothered by the intra-abdominal fat mass and especially by steatotic hepatomegaly (increase in the size of the liver and its fat load).
Faced with this problem, various preoperative strategies such as the placement of an intra gastric balloon have been tried to decrease the size of the liver but a systematic review from 2016 indicates that a low calorie diet is preferable. Preoperative weight loss can reduce fat load and liver volume very rapidly. This meta-analysis shows that all low-calorie, high-protein diets are effective and that the optimal duration (4 weeks), compliance and tolerance are important factors for success.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* Patient eligible for bariatric surgery (according to HAS criteria) whose sleeve gastrectomy is scheduled
* Patient with morbid obesity (BMI ≥ 40)
* Age ≥ 18 years and ≤ 65 years
* Haemoglobinemia ≥ 12 g/dL in men and ≥ 11 g/dL in women
* Patient speaking and understanding French
* Adult having read and understood the information letter and signed the consent form
* Woman of childbearing age with effective / very effective contraception (Cf. CTFG) (estrogen-progestin or intrauterine device or tubal ligation) prior to surgery and a negative -HCG blood pregnancy test at inclusion, for the duration of the study
* Postmenopausal woman: confirmatory diagnosis (non-medically induced amenorrhoea for at least 12 months prior to the inclusion visit)
* Patient affiliated with, or beneficiary of a social security (health insurance) category
Exclusion Criteria:
* Contraindication to bariatric surgery detected during the preoperative assessment
* Medical contraindication to a restrictive diet
* Type I or II insulin-requiring diabetes
* Severe renal insufficiency defined by a blood filtration rate \< 30 mL/min
* Person wearing a pacemaker or any other implant with the same functions (cochlear implant, bladder battery, etc.)
* Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / sub-guardianship or curatorship
* A history of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol or to prevent him/her from giving informed consent
Primary outcome measure(s)
Poor diet tolerance — 4 weeks after the beggining of the diet At least one of the following biological abnormalities at the end of the diet period:
* Lymphopenia acquired during the diet
* Anemia (Hb\<11g/dL for men Hb\<10g/dL for women) or a decrease in hemoglobin of more than 2 g/dL
* Onset or worsening of vitamin B1 deficiency from baseline (Vit B1 \< 78 nmol/L)
OR
At least one of the following clinical abnormalities:
* Decrease in muscle strength (difference in muscle strength measured with a HandGrip at Visit 2 and Visit 3) greater than three standard deviations from the matched Visit 3 - visit 2 differences of the control group after removal of measurement bias on a log-transformed strength variable, associated with weight loss \> 5% in 1 month or a decrease in percent lean mass ≥ 1% relative to visit 2
* Any permanent discontinuation
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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