Kidney Function and Anorexia Nervosa

Anorexia Nervosa Clinical Trial

— ANKID  

Official title:

Pilot Study of Renal Function by a Reference Isotopic Technique in Malnourished Patients With Anorexia Nervosa

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05327998
• Other study ID #: APHP211173
• Secondary ID: 2021-A01538-33
• Status: Recruiting
• Start date: April 8, 2022
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Mouna Hanachi, MD
• Phone: + 33 (0)1.45.59.35.71
• Email: mouna.hanachi[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Kidney Injury

Locations

Country	Name	City	State
France	Department of Nutrition, Paul Brousse hospital, APHP	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Fondation de l'Avenir

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	at 18 months
Secondary	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.	at 18 months