NUTritional Impact of a Hypocaloric Hyperprotein Diet Before Obesity Surgery

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Ch Dieppe
RECRUITING
Dieppe
HPE
RECRUITING
Le Havre
CHU de ROUEN
RECRUITING
Rouen
Contact Information
Primary
Christèle DAVID
christele.david@chu-rouen.fr
+33232888624
Backup
Déborah LEBEDIEFF
deborah.lebedieff@chu-rouen.fr
+33232888265
Time Frame
Start Date: 2023-10-09
Estimated Completion Date: 2027-03-20
Participants
Target number of participants: 200
Treatments
Experimental: With 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
Other: Without diet
A low-calorie, high-protein diet will not be prescribed to the patient for a period of 4 weeks.
Sponsors
Leads: University Hospital, Rouen

This content was sourced from clinicaltrials.gov