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NCT05529199 Clinical Trial

Impact of Preoperative Hypocaloric Hyperproteinic Lipid Restricting Diet on Bariatric Surgery

Obesity, Abdominal Clinical Trial

— LipiDiet  

Official title:
Impact of Preoperative Hypocaloric Hyperproteinic Lipid Restricting Diet on Bariatric Surgery

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05529199
Other study ID # 8689
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 31, 2022
Est. completion date December 2023

Study information
Verified date December 2023
Source University Hospital, Strasbourg, France
Contact Benoit ROMAIN, MD, PhD
Phone 33 3 88 12 72 37
Email benoit.romain@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Obesity is one of the greatest pandemics of the 21st century with 30 million new cases each year. In France each year, 60,000 bariatric surgery procedures are performed. Many preoperative diets have been proposed in the literature with some studies giving positive results. But these diets are often strict and can have adverse effects on metabolism. Very few studies have described the PSMF diet. The hypothesis would be that this diet is associated with a reduction in liver volume with a reduction in steatosis.

Recruitment information / eligibility
Status Recruiting
Enrollment 776
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - Adult patient (=18 years old) - Man and woman - Patient operated on at the HUS between 2010 and 2021 for bariatric surgery - Patient not objecting to the reuse of their data for scientific research purposes. Exclusion criteria: - Patient who has expressed his opposition to the reuse of his data for scientific research purposes.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Service de chirurgie générale et digestive - CHU de Strasbourg - France Strasbourg

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary liver volume measurement in cm Files analysed retrospectively from Ocober 01, 2010 to December 31, 2021 will be examined
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