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Incomplete Total Body Protein Recovery in Adolescent Patients With Anorexia Nervosa

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ClinicalTrials.gov Identifier: NCT03334032
Recruitment Status : Completed
First Posted : November 7, 2017
Last Update Posted : November 7, 2017
Sponsor:
Collaborator:
University of Sydney
Information provided by (Responsible Party):
Dr. Verena Haas, Charite University, Berlin, Germany

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

Condition or disease Intervention/treatment
Anorexia Nervosa Other: Inpatient treatment for Anorexia nervosa

Detailed Description:

Background: Bone health and growth during adolescence require adequate Total Body Protein (TBPr). Re-nutrition for patients with anorexia nervosa (AN) should aim to normalize body composition, i.e. recovery of fat mass and TBPr.

Objective: The study intended to analyze predictors of protein status, including exercise status, in adolescents with AN, and to investigate whether weight gain would replete body protein deficits.

Methods: The investigators assessed TBPr in a longitudinal, observational study as height-adjusted nitrogen index (NI) using in-vivo neutron activation analysis in adolescents with AN at the commencement of refeeding (T0), as well as seven months thereafter (T1), and in age-matched normal weight controls. Lean tissue and fat mass were assessed with Dual-Energy X-Ray Absorptiometry (DXA). BMI, BMI-SDS and lean tissue mass were tested as predictors of protein status using Receiver Operating Characteristic (ROC) analysis.

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Study Type : Observational
Actual Enrollment : 154 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incomplete Total Body Protein Recovery in Adolescent Patients With Anorexia Nervosa
Actual Study Start Date : July 2004
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Group/Cohort Intervention/treatment
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
Nutritional rehabilitation in a clinic with specialized eating disorder service

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



Primary Outcome Measures :
  1. Change in Total Body protein [ Time Frame: Between baseline (inpatient admission) and at 7 months follow-up ]
    Change in Total Body protein


Secondary Outcome Measures :
  1. Change in body weight [ Time Frame: Between baseline (inpatient admission) and at 7 months follow-up ]
    Change in: body weight (kg)

  2. Change in Body Mass Index [ Time Frame: Between baseline (inpatient admission) and at 7 months follow-up ]
    Change in Body Mass Index (BMI; kg/m2)

  3. Change in body fat mass [ Time Frame: Between baseline (inpatient admission) and at 7 months follow-up ]
    Change in body fat mass (kg)

  4. Change in body lean tissue mass [ Time Frame: Between baseline (inpatient admission) and at 7 months follow-up ]
    Change in body lean tissue mass (kg)



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Ages Eligible for Study:   12 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

Patient Inclusion Criteria:

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

Patient Exclusion Criteria:

- existence of a further disease with effect on body composition

Controls:

  • no known disease
  • normal weight

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03334032


Sponsors and Collaborators
Charite University, Berlin, Germany
University of Sydney
Investigators
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Principal Investigator: Michael R Kohn, Prof. University of Sydney
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Responsible Party: Dr. Verena Haas, Principle Investigator, Clinical Researcher, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03334032    
Other Study ID Numbers: TBN in AN
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Verena Haas, Charite University, Berlin, Germany:
Body composition
Total body protein
nutritional recovery
Exercise status
In-vivo neutron activation analysis
Protein depletion
Additional relevant MeSH terms:
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Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders