Cortisol, Hippocampus, and Insula in Anorexia Nervosa.

NCT05931549 | Recruiting

• 1 other identifier: EXCENTRICCAN
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

EXCENTRICC is a platform for scientific collaboration between different disciplines, all working on a common theme: adrenocortical hormones. In this EXCENTRICC sub-study, associations are studied between cortisol levels and depression, anxiety, disease severity and hippocampal and insula volume in the brain in anorexia nervosa.

Conditions

Anorexia Nervosa; Stress

Keywords

anorexia nervosa; Cortisol; Insula; Hippocampus

Outcome Measures

Primary Outcomes (4)

• Hippocampus total volumen (cm3)

  MRI

  Cross sectional (AN patients during a treatment course)

• Insula total volumen (cm3)

  MRI

  (AN patients during a treatment course)

• Plasma cortisol level (mmol/l)

  AN patients during a treatment course at any time in relation to the duration of the illness and course of treatment.

• Cortisol diurnal excretion (nmol/d)

  AN patients during a treatment course at any time in relation to the duration of the illness and course of treatment.

Secondary Outcomes (4)

• Symptom severity

  AN patients during a treatment course at any time in relation to the duration of the illness and course of treatment.

• Depression

  AN patients during a treatment course at any time in relation to the duration of the illness and course of treatment.

• Anxiety

  AN patients during a treatment course at any time in relation to the duration of the illness and course of treatment.

• Quality of life

  AN patients during a treatment course at any time in relation to the duration of the illness and course of treatment.

Study Arms (2)

Patients in treatment for severe anorexia nervosa

Treatment as usual.

Age matched healthy controls

No treatment.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: The disease anorexia nervosa is predominantly observed in women (approximately 95%).
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women with anorexia nervosa, treatment seeking at Center for Eating Disorders at Odense University Hospital or via advertising on social media.

You may qualify if:

• Women who fulfill the criteria for AN according to the Diagnostic and Statistical Manual of Mental Disorders (DSM), version 5 (APA, 2013).
• BMI \< 16.

You may not qualify if:

• Current treatment with glucocorticoids.
• Current use of oral contraceptives.
• Unstable acute somatic comorbidity, e.g., infection.
• Any kind of metal prostheses or -implants.

Sponsors & Collaborators

• Odense University Hospital: lead
• Ruhr University of Bochum: collaborator
• Umeå University: collaborator

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, saliva, urine, hair

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• René K Støving, PhD

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

René K Støving, PhD

CONTACT

65411710; rene.stoeving@rsyd.dk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: July 5, 2023
• Study Start: September 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)