Eating DisordersPré-THETANCT06093919
Study of Prevalence of Eating Disorder in Liver Transplant Patients
An observational study of Eating Disorders and Eating Disorder Binge, run by Centre Hospitalier Henri Laborit at 2 sites in France.
Trial summary
The main goal of this observational study is to measure the prevalence of binge eating disorder in liver transplant patients by evaluating the responses to the Bulimia Test. Secondary objectives of the study are to: Determine the prevalence of binge eating disorders in liver transplant patients following alcoholic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eating Disorders, Eating Disorder Binge, Liver Transplant; Complications
- How many people
- 118 participants
- Where
- 2 sitesFrance
- Study dates
- 12 Feb 2024to 14 Aug 2024
- How long will I take part?
- 1 Year
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of all liver transplant patients at the University Hospital of Poitiers followed between 01/01/2023 and 06/30/2024
Who may be able to join
- over 18 years old
- had a liver transplant and followed at University Hospital of Poitiers
- responded to the Bulimia Test-Revised and to the Alcohol Use Disorders Identification Test-Consumption
- had a Fibroscan within the year
Who cannot join
- Patient without Fibroscan and not responded to both scale : Bulimia Test-Revised and Alcohol Use Disorders Identification Test-Consumption
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Henri Laborit
Poitiers
University Hospital of Poitiers (CHU de Poitiers)
Poitiers
About this study
The main goal of this observational study is to measure the prevalence of binge eating disorder in liver transplant patients by evaluating the responses to the Bulimia Test.
Secondary objectives of the study are to:
- Determine the prevalence of binge eating disorders in liver transplant patients following alcoholic cirrhosis, evaluated by the Bulimia Test;
- Study the association between the presence of eating disorder behaviours and liver damage : hepatic steatosis and fibrosis determined by Fibroscan (Transient elastography and controlled attenuation parameter)
- Study the association between presence of eating disorder behaviours and alcohol use disorder, measured by Alcohol Use Disorders Identification Test-Consumption
- Conditions
- Eating Disorders, Eating Disorder Binge, Liver Transplant; Complications, Alcohol Use Disorder, Cirrhosis Alcoholic
- Medical subject headings
- Feeding and Eating Disorders, Binge-Eating Disorder, Alcoholism, Liver Cirrhosis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Liver transplant patients | This cohort will consist of all liver transplant patients followed between 01/01/2023 and 06/30/2024 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of binge eating disorder in liver transplant patients
The prevalence is defined as the percentage of liver transplant patients with a score higher than 88 on the Bulimia Test-Revised. The Bulimia Test-Revised is a validated test. It is a 36 item self-report questionnaire to assess the presence of bulimic symptoms. Scores range from 29-140 with those greater than 104 being indicative of bulimia nervosa.
Measured: 1 year
Secondary outcomes (3)
Prevalence for binge eating disorder in liver transplant patients following alcoholic cirrhosis
The prevalence was defined as the percentage of liver transplant patients following alcoholic cirrhosis with a score higher than 88 on the Bulimia Test-Revised. The Bulimia Test-Revised is a validated test. It is a 36 item self-report questionnaire to assess the presence of bulimic symptoms. Scores range from 29-140 with those greater than 104 being indicative of bulimia nervosa.
Measured: 1 year
Correlation between the BulimiaTest-Revised score and liver damage determined by the Fibroscan
The Correlation was defined by the coefficient between the bulimia-Test score and the liver damage defined by the levels of hepatic steatosis and fibrosis witch are measured by Transient elastography and controlled attenuation parameter using Fibroscan. The Bulimia Test-Revised is a validated, it is a 36 item self-report questionnaire to assess the presence of bulimic symptoms. Scores range from 29-140 with those greater than 104 being indicative of bulimia nervosa.
Measured: 1 year
Correlation between the Bulimia-Test score and the Alcohol Use Disorders Identification Test-Consumption score
The Correlation was defined by the coefficient between the bulimia-Test score and the Alcohol Use Disorders Identification Test-Consumption score. The Bulimia Test-Revised is a validated. It is a 36 item self-report questionnaire to assess the presence of bulimic symptoms. Scores range from 29-140 with those greater than 104 being indicative of bulimia nervosa.
The Alcohol Use Disorders Identification Test-Consumption score is a validated test. It's scored on a scale of 0-12 (scores of 0 reflect no alcohol use). For men, a score of 4 or more is considered positive; for women, a score of 3 or more is considered positive. Generally, the higher the AUDIT-C score, the more likely the patient's drinking is affecting his/her health and safety.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start12 Feb 2024
- Primary completion30 Jun 2024
- Study completion14 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 118 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Henri Laborit
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093919
- Sponsor's protocol ID
- F20230719110020
- Acronym
- Pré-THETA
- Status last verified
- Aug 2024
- First submitted
- 17 Oct 2023
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Prevalence of Eating Disorder in Liver Transplant Patients
- ClinicalTrials.gov ID
- NCT06093919
- Acronym / sponsor ID
- Pré-THETA / F20230719110020
- Conditions
- Eating Disorders, Eating Disorder Binge, Liver Transplant; Complications, Alcohol Use Disorder, Cirrhosis Alcoholic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Centre Hospitalier Henri LaboritUniversity, hospital or other
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 14 Aug 2024 (actual)
- First posted
- 23 Oct 2023 (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.
The main goal of this observational study is to measure the prevalence of binge eating disorder in liver transplant patients by evaluating the responses to the Bulimia Test.
Secondary objectives of the study are to:
- Determine the prevalence of binge eating disorders in liver transplant patients following alcoholic cirrhosis, evaluated by the Bulimia Test;
- Study the association between the presence of eating disorder behaviours and liver damage : hepatic steatosis and fibrosis determined by Fibroscan (Transient elastography and controlled attenuation parameter)
- Study the association between presence of eating disorder behaviours and alcohol use disorder, measured by Alcohol Use Disorders Identification Test-Consumption
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver transplant patients | – | –This cohort will consist of all liver transplant patients followed between 01/01/2023 and 06/30/2024 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of all liver transplant patients at the University Hospital of Poitiers followed between 01/01/2023 and 06/30/2024
Key inclusion criteria (4 listed)
- over 18 years old
- had a liver transplant and followed at University Hospital of Poitiers
- responded to the Bulimia Test-Revised and to the Alcohol Use Disorders Identification Test-Consumption
- had a Fibroscan within the year
Key exclusion criteria (1 listed)
- Patient without Fibroscan and not responded to both scale : Bulimia Test-Revised and Alcohol Use Disorders Identification Test-Consumption
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
Prevalence of binge eating disorder in liver transplant patients
Time frame: 1 year
The prevalence is defined as the percentage of liver transplant patients with a score higher than 88 on the Bulimia Test-Revised. The Bulimia Test-Revised is a validated test. It is a 36 item self-report questionnaire to assess the presence of bulimic symptoms. Scores range from 29-140 with those greater than 104 being indicative of bulimia nervosa.
3 secondary outcomes
Prevalence for binge eating disorder in liver transplant patients following alcoholic cirrhosis
Time frame: 1 year
Correlation between the BulimiaTest-Revised score and liver damage determined by the Fibroscan
Time frame: 1 year
Correlation between the Bulimia-Test score and the Alcohol Use Disorders Identification Test-Consumption score
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eating Disorders and Eating Disorder Binge, run by Centre Hospitalier Henri Laborit at 2 sites 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: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of binge eating disorder in liver transplant patients (time frame: 1 year). 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 20 Aug 2024.