Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000572460
Ethics application status
Approved
Date submitted
28/04/2016
Date registered
3/05/2016
Date last updated
30/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Appetite hormones in anorexia nervosa
Scientific title
Appetite Regulatory Hormones in Adolescents Undergoing First Refeeding for Anorexia Nervosa
Secondary ID [1] 289094 0
Nil
Universal Trial Number (UTN)
Trial acronym
ARHAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anorexia nervosa 298553 0
Condition category
Condition code
Mental Health 298641 298641 0 0
Eating disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 294601 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298131 0
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.
Timepoint [1] 298131 0
Change from baseline to 12 months from initial refeeding.
Secondary outcome [1] 323243 0
Changes in appetite hormones from baseline to other time points (i.e. not 12 months).
These will be assessed by serum assay.
Timepoint [1] 323243 0
2, 4, 8, 16 weeks, 6 months from initial refeeding admission

Eligibility
Key inclusion criteria
New admission for treatment of anorexia nervosa.
Age 14-20
Minimum age
14 Years
Maximum age
20 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age <14 or age >20.
Not first admission for treatment of anorexia (i.e. second or subsequent presentation).

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Paired testing comparing baseline to the time point. We estimate that 50 subjects tested at 12 months should be sufficient to have >80% power to detect differences of clinically relevant magnitude at the p<0.05 level. These would be >10% change in absolute results. Because of the age and relatively high mobility of the participant population, it is likely that many subjects will not have 12 month samples collected, hence the larger number of intake subjects (i.e. up to 200).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/05/2016
Actual
Date of last participant enrolment
Anticipated
16/05/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5698 0
Westmead Hospital - Westmead

Funding & Sponsors
Funding source category [1] 293470 0
Hospital
Name [1] 293470 0
Westmead Hospital
Country [1] 293470 0
Australia
Primary sponsor type
Hospital
Name
Dept of Endocrinology and Diabetes, Westmead Hospital
Address
Department of Endocrinology and Diabetes,
Westmead Hospital.
Cnr Darcy and Hospital Roads,
Westmead. NSW. 2145
Country
Australia
Secondary sponsor category [1] 292293 0
None
Name [1] 292293 0
None
Address [1] 292293 0
None
Country [1] 292293 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294912 0
Western Sydney Local Health District
Ethics committee address [1] 294912 0
Ethics committee country [1] 294912 0
Australia
Date submitted for ethics approval [1] 294912 0
01/10/2015
Approval date [1] 294912 0
26/02/2016
Ethics approval number [1] 294912 0
SSA/15/WMEAD/404

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65442 0
Prof Jenny Gunton
Address 65442 0
Room 2040, Level 2,
Westmead Hospital,
Cnr Darcy and Hospital Roads,
Westmead. NSW. 2145
Country 65442 0
Australia
Phone 65442 0
+61 2 9845 8089
Fax 65442 0
Email 65442 0
[email protected]
Contact person for public queries
Name 65443 0
Jenny Gunton
Address 65443 0
Room 2040, Level 2,
Westmead Hospital,
Cnr Darcy and Hospital Roads,
Westmead. NSW. 2145
Country 65443 0
Australia
Phone 65443 0
+61298458089
Fax 65443 0
Email 65443 0
[email protected]
Contact person for scientific queries
Name 65444 0
Jenny Gunton
Address 65444 0
Room 2040, Level 2,
Westmead Hospital,
Cnr Darcy and Hospital Roads,
Westmead. NSW. 2145
Country 65444 0
Australia
Phone 65444 0
+61298458089
Fax 65444 0
Email 65444 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.