Obesity, AbdominalLipiDietNCT05529199
Impact of Preoperative Hypocaloric Hyperproteinic Lipid Restricting Diet on Bariatric Surgery
An observational study of Obesity, Abdominal, run by University Hospital, Strasbourg, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Abdominal
- How many people
- 776 participants
- Where
- 1 siteFrance
- Study dates
- 31 Aug 2022to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients (≥18 years old) operated on at the HUS between 2010 and 2021 for bariatric surgery
Who may be able to join
- 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.
Who cannot join
- Patient who has expressed his opposition to the reuse of his data for scientific research purposes.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de chirurgie générale et digestive - CHU de Strasbourg - France
Strasbourg, 67091
Benoit ROMAIN, MD, PhD, 33 3 88 12 72 37, benoit.romain@chru-strasbourg.fr
Benoit ROMAIN, MD, PhD
About this study
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.
- Conditions
- Obesity, Abdominal
- Keywords
- Obesity, Abdominal, Preoperative diets, PSMF diet
- Medical subject headings
- Obesity, Abdominal
What is being measured
The primary outcome is the main question the study is designed to answer.
liver volume measurement in cm
Measured: Files analysed retrospectively from Ocober 01, 2010 to December 31, 2021 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start31 Aug 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, AbdominalStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 776 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoit ROMAIN, MD, PhD, Principal investigator, Service de chirurgie générale et digestive - CHU de Strasbourg - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529199
- Sponsor's protocol ID
- 8689
- Acronym
- LipiDiet
- Status last verified
- Dec 2023
- First submitted
- 30 Aug 2022
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Preoperative Hypocaloric Hyperproteinic Lipid Restricting Diet on Bariatric Surgery
- ClinicalTrials.gov ID
- NCT05529199
- Acronym / sponsor ID
- LipiDiet / 8689
- Conditions
- Obesity, Abdominal
- Keywords
- Obesity, Abdominal, Preoperative diets, PSMF diet
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 776 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 6 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years old) operated on at the HUS between 2010 and 2021 for bariatric surgery
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Patient who has expressed his opposition to the reuse of his data for scientific research purposes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
liver volume measurement in cm
Time frame: Files analysed retrospectively from Ocober 01, 2010 to December 31, 2021 will be examined
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benoit ROMAIN, MD, PhD principal investigator
Service de chirurgie générale et digestive - CHU de Strasbourg - France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Abdominal, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benoit ROMAIN, MD, PhD (33 3 88 12 72 37, benoit.romain@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
liver volume measurement in cm (time frame: Files analysed retrospectively from Ocober 01, 2010 to December 31, 2021 will be examined). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.