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OpenTrials
Completed

NCT Number: NCT05327998

Kidney Function and 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Nutrition, Paul Brousse hospital, APHP

Villejuif, 94800, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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).

Secondary outcomes

  1. Cystatin C and predictive formulas for measuring GFR from blood creatinine level

    Time frame: at 18 months

    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.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Fondation de l'Avenir

Registry information

Official study title

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

Acronym: ANKID

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 14, 2022
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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