NCT04942093Recruiting
NUTritional Impact of a Hypocaloric Hyperprotein Diet Before Obesity Surgery
Source: ClinicalTrials.gov · Last updated 22 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 11 Jun 2021
- Start date
- 9 Oct 2023
- Primary completion date
- 20 Nov 2026
- Lead sponsor
- University Hospital, Rouen
- Diseases
- Obesity
- NCT number
- NCT04942093
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 9 Oct 2023 to the primary completion date, 20 Nov 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindication to bariatric surgery detected during the preoperative assessment
- Person wearing a pacemaker or any other implant with the same functions (cochlear implant, bladder battery, etc.)
Other illness
- Type I or II insulin-requiring diabetes
- Severe renal insufficiency defined by a blood filtration rate \< 30 mL/min
- 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
Other
- Medical contraindication to a restrictive diet
- Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / sub-guardianship or curatorship
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ch Dieppe Coordinator of this site? Confirm its status | Dieppe | France | Recruiting |
| HPE Coordinator of this site? Confirm its status | Le Havre | France | Recruiting |
| CHU de Rouen Coordinator of this site? Confirm its status | Rouen | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.