Incomplete Total Body Protein Recovery in Adolescent Patients With Anorexia Nervosa

NCT03334032 | Completed

• 1 other identifier: TBN in AN
• Study Type: observational
• Target: 154
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study aimed to assess protein accretion during weight gain in adolescent patients with Anorexia nervosa

Conditions

Anorexia Nervosa

Keywords

Body composition; Total body protein; nutritional recovery; Exercise status; In-vivo neutron activation analysis; Protein depletion

Outcome Measures

Primary Outcomes (1)

• Change in Total Body protein

  Change in Total Body protein

  Between baseline (inpatient admission) and at 7 months follow-up

Secondary Outcomes (4)

• Change in body weight

  Between baseline (inpatient admission) and at 7 months follow-up

• Change in Body Mass Index

  Between baseline (inpatient admission) and at 7 months follow-up

• Change in body fat mass

  Between baseline (inpatient admission) and at 7 months follow-up

• Change in body lean tissue mass

  Between baseline (inpatient admission) and at 7 months follow-up

Study Arms (2)

Inpatient treatment for Anorexia nervosa

Adolescents with anorexia nervosa assessed 1. at baseline: on admission to inpatient treatment 2. at follow-up: 6 months after admission on outpatient basis

Other: Inpatient treatment for Anorexia nervosa

Controls

Adolescent healthy and normal weight controls (matched for gender and age), assessed at one point of time

Interventions

Inpatient treatment for Anorexia nervosa OTHER

Nutritional rehabilitation in a clinic with specialized eating disorder service

Inpatient treatment for Anorexia nervosa

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

At baseline assessment, ten patients had primary amenorrhea and 87 girls secondary amenorrhea. Six girls were not amenorrhoeic but were taking oral contraceptives or had lost more than 20% of their weight and fulfilled the remaining diagnostic criteria for AN. The mean duration of the eating disorder at the time of testing was 15 ± 12 months, ranging from 3 to 60 months and estimated premorbid BMI of the AN patients was 20.4 ± 2.9 (13.5 - 28.7 kg/m2; data available for 98 patients). Before admission, the patients (n = 97) had lost 15 ± 7 (2 - 36) kg. The mean weight on hospital admission (data available for 88 patients; 10 patients were outpatients; missing data, n = 5) was 41.1 ± 6.1 kg.

You may qualify if:

• diagnosis of anorexia nervosa (DSM-IV)
• aged 12 - 19 years
• female gender

You may not qualify if:

• \- existence of a further disease with effect on body composition
• Controls:
• no known disease
• normal weight

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• University of Sydney: collaborator

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Hospitalization

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Michael R Kohn, Prof.

  University of Sydney

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator, Clinical Researcher

Study Record Dates

• First Submitted: October 29, 2017
• First Posted: November 7, 2017
• Study Start: July 1, 2004
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: November 7, 2017

Record last verified: 2017-11