Impact of Preoperative Hypocaloric Hyperproteinic Lipid Restricting Diet on Bariatric Surgery (LipiDiet)

December 12, 2023 updated by: University Hospital, Strasbourg, France

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

776

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service de chirurgie générale et digestive - CHU de Strasbourg - France
        • Contact:
        • Principal Investigator:
          • Benoit ROMAIN, MD, PhD
        • Sub-Investigator:
          • Jean Baptiste BERTIN, MD
        • Sub-Investigator:
          • Samer DIAB, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adult patients (≥18 years old) operated on at the HUS between 2010 and 2021 for bariatric surgery

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
liver volume measurement in cm
Time Frame: Files analysed retrospectively from Ocober 01, 2010 to December 31, 2021 will be examined
Files analysed retrospectively from Ocober 01, 2010 to December 31, 2021 will be examined

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Benoit ROMAIN, MD, PhD, Service de chirurgie générale et digestive - CHU de Strasbourg - France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2022

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

August 30, 2022

First Submitted That Met QC Criteria

September 1, 2022

First Posted (Actual)

September 6, 2022

Study Record Updates

Last Update Posted (Actual)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 12, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8689

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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