NCT06800742 Body Composition in Adolescents With Anorexia Nervosa
| NCT ID | NCT06800742 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Auxologico Italiano |
| Condition | Anorexia Nervosa |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-07-12 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2024-07-12 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Body Mass Index (BMI) is currently the most widely recommended parameter for identifying underweight subjects. Among eating disorder diseases, anorexia nervosa (AN) is the one with the highest mortality rate and with relapses between 12 and 27%. To date, recovery programs allow approximately 40% of subjects to achieve recovery, 30% demonstrate improvements, and 20% remain chronically affected. These data demonstrate the importance of continuously monitoring changes in weight and body composition of these subjects. Bioelectrical impedance (BIA) is widely used to determine body composition in AN. BIA provides various parameters, such as lean mass (LM), fat mass (FM), total body water (TBW), and phase angle (PhA). Among these parameters, in addition to LM and FM, PhA has also been used to characterize underweight subjects with AN. In addition to the observed relationship between PhA and body composition in individuals with AN, PhA has also been related to the basal metabolic rate (BMR). BMR undergoes changes mainly due to loss of muscle mass and a significant reduction in BMR has been observed in AN subjects. Finally, physical activity represents a significant determinant of body composition and can help regulate BMR. Therefore, monitoring changes in body composition (LM, FM, and PhA) and indirect indices (lean mass index and fat mass index) using BIA, together with monitoring changes in BMR and physical activity level, could provide important support for the continuous control and definition of the clinical stage of the disease in patients with AN. The aim of this study is to determine body composition, basal metabolic rate, and level of physical activity in Anorexia Nervosa and normal weight subjects to identify the most consistent parameters to define the clinical stage of the disease in subjects with AN.
Eligibility Criteria
Adolescents with Anorexia Nervosa: Inclusion Criteria: * Female sex * Age range: 12-18 years * Anorexia nervosa * Hospitalized at the Division of Auxologia, San Giuseppe Hospital, Istituto Auxologico Italiano, IRCCS, Piancavallo, Italy Exclusion Criteria: * Absence of signed informed consent Adolescents with normal weight: Inclusion Criteria: * Female sex * Age range: 12-18 years * Normal weight Exclusion Criteria: * Absence of signed informed consent
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06800742 clinical trial?
This trial is open to female participants only, aged 12 Years or older, up to 18 Years, studying Anorexia Nervosa. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06800742 currently recruiting?
Yes, NCT06800742 is actively recruiting participants. Contact the research team at sartorio@auxologico.it for enrollment information.
Where is the NCT06800742 trial being conducted?
This trial is being conducted at Oggebbio, Italy.
Who is sponsoring the NCT06800742 clinical trial?
NCT06800742 is sponsored by Istituto Auxologico Italiano. The trial plans to enroll 60 participants.