Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ANZCTR |
Last refreshed on:
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13 January 2020 |
Main ID: |
ACTRN12616000572460 |
Date of registration:
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03/05/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Appetite hormones in anorexia nervosa
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Scientific title:
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Appetite Regulatory Hormones in Adolescents Undergoing First Refeeding for Anorexia Nervosa |
Date of first enrolment:
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16/05/2016 |
Target sample size:
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200 |
Recruitment status: |
Recruiting |
URL:
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https://anzctr.org.au/ACTRN12616000572460.aspx |
Study type:
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Observational |
Study design:
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Purpose: Natural history;Duration: Longitudinal;Selection: Defined population;Timing: Prospective;
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Phase:
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Not Applicable
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Countries of recruitment
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Australia
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Contacts
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Name:
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Prof Jenny Gunton
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Address:
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Room 2040, Level 2,
Westmead Hospital,
Cnr Darcy and Hospital Roads,
Westmead. NSW. 2145
Australia |
Telephone:
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+61298458089 |
Email:
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jenny.gunton@sydney.edu.au |
Affiliation:
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Name:
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Prof Jenny Gunton
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Address:
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Room 2040, Level 2,
Westmead Hospital,
Cnr Darcy and Hospital Roads,
Westmead. NSW. 2145
Australia |
Telephone:
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+61298458089 |
Email:
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jenny.gunton@sydney.edu.au |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: New admission for treatment of anorexia nervosa.
Age 14-20
Exclusion criteria: Age <14 or age >20.
Not first admission for treatment of anorexia (i.e. second or subsequent presentation).
Age minimum:
14 Years
Age maximum:
20 Years
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Mental Health - Eating disorders
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Anorexia nervosa; Anorexia nervosa
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Intervention(s)
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Nil interventions - all subjects will have routine clinical care. Mostly they are inpatients for the first 4 weeks and will have baseline, 1, 2 and 4 week bloods collected to measure appetite peptides. Then they attend outpatients at roughly monthly intervals until stable. We will collect blood samples to measure appetite peptides at the outpatient visits most closely approximating 8, 16 and 26 weeks and 12 months.. We will observe weight regain and maintenance over the study period. Weight will be measured each visit with scales to the nearest 0.1kg, height will be assessed by stadiometer at first visit.
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Primary Outcome(s)
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Change in appetite peptides in relation to weight regain. The hormones will be assessed by ELISAs. Weight change will be assessed as above using digital scales recorded to the nearest 0.1kg.[Change from baseline to 12 months from initial refeeding.]
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Secondary Outcome(s)
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Changes in appetite hormones from baseline to other time points (i.e. not 12 months).
These will be assessed by serum assay.[2, 4, 8, 16 weeks, 6 months from initial refeeding admission]
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Source(s) of Monetary Support
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Westmead Hospital
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Ethics review
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Status: Approved
Approval date:
Contact:
Western Sydney Local Health District
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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