Low-calorie, high-protein diet before weight-loss surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial compares a preoperative low-calorie, high-protein dietary program to no specific preoperative diet in adults scheduled for sleeve gastrectomy. Participants who meet inclusion criteria will be assigned to either receive the diet for the preoperative period or continue usual care, with adherence and tolerance monitored. Primary outcomes focus on liver size/fat load and preoperative weight loss, and secondary outcomes include surgical conditions and short-term perioperative safety. The design follows prior evidence suggesting a roughly 4-week diet can rapidly reduce liver volume, and the study will measure whether that translates into clinical benefits.

Why it matters

Who can join: the full rules

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

Where it's running

• Ch Dieppe
  Dieppe, France Recruiting
• Hpe
  Le Havre, France Recruiting
• CHU de ROUEN
  Rouen, France Recruiting

Study contacts

• Study coordinator: Christèle DAVID
• Email: christele.david@chu-rouen.fr
• Phone: +33232888624

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.