Actively Recruiting
NUTritional Impact of a Hypocaloric Hyperprotein Diet Before Obesity Surgery
Led by University Hospital, Rouen · Updated on 2025-09-22
200
Participants Needed
3
Research Sites
179 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
NUTritional Impact of a Hypocaloric Hyperprotein Diet Before Obesity Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient eligible for bariatric surgery with scheduled sleeve gastrectomy
- Morbid obesity with BMI greater than or equal to 40
- Age between 18 and 65 years
- Hemoglobinemia at least 12 g/dL for men and at least 11 g/dL for women
- Ability to speak and understand French
- Adult who has read, understood, and signed the consent form
- Women of childbearing age using effective contraception and negative pregnancy test at inclusion
- Postmenopausal women with confirmed diagnosis of amenorrhea for at least 12 months
- Affiliated with or beneficiary of social security health insurance
You will not qualify if you...
- Contraindications to bariatric surgery found during preoperative assessment
- Medical contraindications to a restrictive diet
- Type I or II diabetes requiring insulin
- Severe kidney failure with filtration rate below 30 mL/min
- Having a pacemaker or similar implant (e.g., cochlear implant, bladder battery)
- Being deprived of liberty by legal decision or under judicial protection, guardianship, or curatorship
- History of illness or psychological or sensory issues preventing understanding of the study or informed consent
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Ch Dieppe
Dieppe, France
Actively Recruiting
2
HPE
Le Havre, France
Actively Recruiting
3
CHU de ROUEN
Rouen, France, 76 000
Actively Recruiting
Research Team
C
Christèle DAVID
CONTACT
D
Déborah LEBEDIEFF
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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