Kidney Function and Anorexia Nervosa

NCT05327998 | Completed

• 2 other identifiers: APHP2111732021-A01538-33
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anorexia Nervosa; Kidney Injury

Keywords

anorexia nervosa; renal function; undernutrition; eating disorder; glomerular filtration rate (GFR); cystatin C

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  at 18 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with anorexia nervosa

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Fondation de l'Avenir: collaborator

Study Sites (1)

Department of Nutrition, Paul Brousse hospital, APHP

Villejuif, 94800, France

Location

MeSH Terms

Conditions

Anorexia Nervosa; Malnutrition; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mouna Hanachi, MD

  Department of Nutrition, Paul Brousse hospital, APHP

  PRINCIPAL INVESTIGATOR

• Marika Dicembre, Master's

  Department of Nutrition, Paul Brousse hospital, APHP

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 14, 2022
• Study Start: April 8, 2022
• Primary Completion: March 5, 2025
• Study Completion: March 5, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)