Anorexia NervosaANKIDNCT05327998
Kidney Function and Anorexia Nervosa
An observational study of Anorexia Nervosa and Kidney Injury, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Anorexia nervosa (AN) is an eating disorder that can lead to severe medical complications. Kidney injuries are unknown in patients with extremely malnourished AN (BMI <13). The primary objective of the study is to evaluate the frequency and to determine the profiles of patients who may develop kidney injuries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anorexia Nervosa, Kidney Injury
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 8 Apr 2022to 5 Mar 2025
- 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: Patients with anorexia nervosa
Who may be able to join
- Patient with undernutrition (BMI < 18,5);
- Patient with AN according to DSM-5 criteria, validated by Eating Disorder Diagnostic Scale and EDDS-questionnaire;
- Patient informed and signed a consent form;
- Patient affiliated to a social security plan.
Who cannot join
- Patient no-reponding to all criteria of DSM-5;
- Patient with a renal comorbidity no-related to AN;
- Patient under AME scheme;
- Pregnancy or breastfeeding;
- Participation to another interventional study.
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Nutrition, Paul Brousse hospital, APHP
Villejuif, 94800
About this study
Official title: Pilot Study of Renal Function by a Reference Isotopic Technique in Malnourished Patients With Anorexia Nervosa
Anorexia nervosa (AN) is an eating disorder that can lead to severe medical complications. Kidney injuries are unknown in patients with extremely malnourished AN (BMI <13). The primary objective of the study is to evaluate the frequency and to determine the profiles of patients who may develop kidney injuries. The secondary objective is to evaluate the evolution of kidney injuries after a phase of refeeding. Guidelines for medical treatments and dietary intakes will be recommended to avoid severe or irreversible renal disease.
Read the detailed description
Anorexia nervosa is an eating disorder that can lead to undernutrition and severe somatic complications. The clinical nutrition unit in Paul Brousse hospital provide care to adult patients with a severe forms of AN. Kidney complications are poorly known and little explored. Indeed, patients suffering from AN have a higher prevalence of kidney failure due to the absence of a reference methods. Kidney injuries come from multiple origin like chronic ionic disorders, dehydration and hyperprotein diet. The aim of this study will be to evaluate kidney injuries and to follow its evolution during refeeding. Blood and urine simple of Cystatine C will be add to routine analyses. This will allow us to know if, there is a concordance between the reference technique (measurement of glomerular filtration rate by isotopic method 99mTC-DTPA) and the measurement of Cystatin C. Thus, guidelines of dietary intake and medical treatments can be achieved in order to prevent severe forms requiring dialysis and kidney transplantation.
- Conditions
- Anorexia Nervosa, Kidney Injury
- Keywords
- anorexia nervosa, renal function, undernutrition, eating disorder, glomerular filtration rate (GFR), cystatin C
- Medical subject headings
- Anorexia Nervosa, Malnutrition, Feeding and Eating Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
DFG measurement
Measurement of glomerular filtration rate by 99mTc-DTPA isotopic technic.
Glomerular Filtration Rate (GFR) measurement by isotopic technique remains the best quantitative marker of kidney function. It allows the diagnosis and the classification of the severity of chronic kidney disease into five stages. Several methods and radiopharmaceutical markers have been developed. The main radiopharmaceuticals used are technetium-labeled diethylene-triamino-penta-acetate (99mTC-DTPA), iodine-labeled iothalamate (125I-iothalamate), and chromium-51-labeled ethylenediaminetetraacetic acid (I51Cr-EDTA). The main advantages of these compounds are : high assay accuracy and a rapid distribution. They can be used in urinary and plasma clearance alternatively. The limitations regarding radioactive products, even if the irradiation remains very low (4% of the dose received during a thoracic radiography).
Measured: at 18 months
Secondary outcomes (1)
Cystatin C and predictive formulas for measuring GFR from blood creatinine level
Cystatin C is secreted by all cell nuclei in the body, filtered by the glomeruli and catabolized in the proximal tubule. Its concentration in the blood is independent of muscle mass. Its level would be better correlated to glomerular filtration measured by 51Cr-EDTA.
Measured: at 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start8 Apr 2022
- Primary completion5 Mar 2025
- Study completion5 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de l'Avenir
- Responsible party
- Sponsor
- Investigators
- Mouna Hanachi, MD, Principal investigator, Department of Nutrition, Paul Brousse hospital, APHPMarika Dicembre, Master's, Study director, Department of Nutrition, Paul Brousse hospital, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327998
- Sponsor's protocol ID
- APHP211173
- Other IDs
- 2021-A01538-33
- Acronym
- ANKID
- Status last verified
- Mar 2025
- First submitted
- 7 Apr 2022
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Renal Function by a Reference Isotopic Technique in Malnourished Patients With Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT05327998
- Acronym / sponsor ID
- ANKID / APHP211173
- Conditions
- Anorexia Nervosa, Kidney Injury
- Keywords
- anorexia nervosa, renal function, undernutrition, eating disorder, glomerular filtration rate (GFR), cystatin C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Fondation de l'Avenir
- Study start
- 8 Apr 2022 (actual)
- Primary completion
- 5 Mar 2025 (actual)
- Study completion
- 5 Mar 2025 (actual)
- First posted
- 14 Apr 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.
Anorexia nervosa (AN) is an eating disorder that can lead to severe medical complications. Kidney injuries are unknown in patients with extremely malnourished AN (BMI <13). The primary objective of the study is to evaluate the frequency and to determine the profiles of patients who may develop kidney injuries. The secondary objective is to evaluate the evolution of kidney injuries after a phase of refeeding. Guidelines for medical treatments and dietary intakes will be recommended to avoid severe or irreversible renal disease.
Detailed description
Anorexia nervosa is an eating disorder that can lead to undernutrition and severe somatic complications. The clinical nutrition unit in Paul Brousse hospital provide care to adult patients with a severe forms of AN. Kidney complications are poorly known and little explored. Indeed, patients suffering from AN have a higher prevalence of kidney failure due to the absence of a reference methods. Kidney injuries come from multiple origin like chronic ionic disorders, dehydration and hyperprotein diet. The aim of this study will be to evaluate kidney injuries and to follow its evolution during refeeding. Blood and urine simple of Cystatine C will be add to routine analyses. This will allow us to know if, there is a concordance between the reference technique (measurement of glomerular filtration rate by isotopic method 99mTC-DTPA) and the measurement of Cystatin C. Thus, guidelines of dietary intake and medical treatments can be achieved in order to prevent severe forms requiring dialysis and kidney transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with anorexia nervosa
Key inclusion criteria (4 listed)
- Patient with undernutrition (BMI < 18,5);
- Patient with AN according to DSM-5 criteria, validated by Eating Disorder Diagnostic Scale and EDDS-questionnaire;
- Patient informed and signed a consent form;
- Patient affiliated to a social security plan.
Key exclusion criteria (5 listed)
- Patient no-reponding to all criteria of DSM-5;
- Patient with a renal comorbidity no-related to AN;
- Patient under AME scheme;
- Pregnancy or breastfeeding;
- Participation to another interventional study.
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
DFG measurement
Time frame: at 18 months
Measurement of glomerular filtration rate by 99mTc-DTPA isotopic technic. Glomerular Filtration Rate (GFR) measurement by isotopic technique remains the best quantitative marker of kidney function. It allows the diagnosis and the classification of the severity of chronic kidney disease into five stages. Several methods and radiopharmaceutical markers have been developed. The main radiopharmaceuticals used are technetium-labeled diethylene-triamino-penta-acetate (99mTC-DTPA), iodine-labeled iothalamate (125I-iothalamate), and chromium-51-labeled ethylenediaminetetraacetic acid (I51Cr-EDTA). The main advantages of these compounds are : high assay accuracy and a rapid distribution. They can be used in urinary and plasma clearance alternatively. The limitations regarding radioactive products, even if the irradiation remains very low (4% of the dose received during a thoracic radiography).
1 secondary outcome
Cystatin C and predictive formulas for measuring GFR from blood creatinine level
Time frame: at 18 months
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 19 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Anorexia Nervosa
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Neuroscience-informed Treatment to Remotely Target Reward Mechanisms in Post-acute Anorexia Nervosa
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Specialist Supportive Clinical Management (SSCM) for Children and Adolescents With Anorexia Nervosa and Atypical Anorexia Nervosa
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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.
Mouna Hanachi, MD principal investigator
Department of Nutrition, Paul Brousse hospital, APHP
Marika Dicembre, Master's study director
Department of Nutrition, Paul Brousse hospital, APHP
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 Anorexia Nervosa and Kidney Injury, run by Assistance Publique - Hôpitaux de Paris 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 5 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 19 Mar 2025. 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?
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?
DFG measurement (time frame: at 18 months). 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 19 Mar 2025.