Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000843459
Ethics application status
Approved
Date submitted
22/06/2016
Date registered
28/06/2016
Date last updated
13/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Weight gain and appetite changes following treatment for thyrotoxicosis – a pilot study
Scientific title
Weight gain and appetite changes following treatment for thyrotoxicosis – a pilot study
Secondary ID [1] 289517 0
Nil
Universal Trial Number (UTN)
U1111-1184-5563
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thyrotoxicosis 299221 0
Condition category
Condition code
Metabolic and Endocrine 299229 299229 0 0
Thyroid disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Assessment of weight and appetite changes in response to treatment for thyrotoxicosis

Participants will be weighed on digital scales and asked to complete and appetite questionnaire and assessment of appetite on a 100mm visual analogue scale whilst fasting. This will take about 10 minutes.
Each participant will complete the assessment session at enrolment, 6 weeks, 6 months and 12 months.
Intervention code [1] 295109 0
Not applicable
Comparator / control treatment
Patients who are euthyroid with structural thyroid disease

Participants will be weighed on digital scales and asked to complete and appetite questionnaire and assessment of appetite on a 100mm visual analogue scale whilst fasting. This will take about 10 minutes. This group will also undergo assessments at 4 time points i.e. baseline, 6 weeks, 6 months and 12 months.
Control group
Active

Outcomes
Primary outcome [1] 298714 0
Change in body weight from baseline measured using digital scales
Timepoint [1] 298714 0
Baseline, 6 weeks, 6 months and 12 months
Secondary outcome [1] 325035 0
Alteration in appetite based on assessment using visual analogue scale
Timepoint [1] 325035 0
Baseline, 6 weeks, 6 months and 12 months
Secondary outcome [2] 325123 0
Alteration in appetite by assessment of a questionnaire - Three Factor Eating Questionnaire
Timepoint [2] 325123 0
Baseline, 6 weeks, 6 months and 12 months

Eligibility
Key inclusion criteria
Patients presenting with overt thyrotoxicosis
Able to consent

For controls - normal thyroid function, able to consent, being assessed in thyroid clinic for structural thyroid disease e.g. nodule
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to consent
Subclinical thyrotoxicosis
Current pregnancy or pregnancy within the past 6 months

These exclusions are the same for both participants and controls

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
This is a pilot study to assess feasibility and depending on results will be used to design a larger study with appropriate power calculations.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2016
Actual
15/08/2016
Date of last participant enrolment
Anticipated
31/10/2016
Actual
3/10/2016
Date of last data collection
Anticipated
8/09/2017
Actual
3/10/2017
Sample size
Target
20
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 7981 0
New Zealand
State/province [1] 7981 0
Waikato

Funding & Sponsors
Funding source category [1] 293888 0
University
Name [1] 293888 0
University of Auckland
Country [1] 293888 0
New Zealand
Primary sponsor type
Hospital
Name
Waikato Hospital
Address
Waikato Hospital
Private Bag 3200
Hamilton 3240
Country
New Zealand
Secondary sponsor category [1] 292715 0
None
Name [1] 292715 0
Address [1] 292715 0
Country [1] 292715 0
Other collaborator category [1] 279045 0
Individual
Name [1] 279045 0
Associate Professor John V Conaglen
Address [1] 279045 0
Waikato Hospital
Private Bag 3200
Hamilton 3240
Country [1] 279045 0
New Zealand
Other collaborator category [2] 279046 0
Individual
Name [2] 279046 0
Dr Jade Tamatea
Address [2] 279046 0
Waikato Hospital
Private Bag 3200
Hamilton 3240
Country [2] 279046 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295308 0
Northern Y Regional Ethics committee
Ethics committee address [1] 295308 0
Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington 6011
Ethics committee country [1] 295308 0
New Zealand
Date submitted for ethics approval [1] 295308 0
08/06/2016
Approval date [1] 295308 0
20/07/2016
Ethics approval number [1] 295308 0
16/CEN/78

Summary
Brief summary
Thyrotoxicosis is a common endocrine disorder. During the time an individual is hyperthyroid with untreated thyrotoxicosis, despite an increase in appetite weight loss is commonly reported. Most patients with thyrotoxicosis are initially treated with anti-thyroid medications to achieve a euthyroid state. With restoration of normal thyroid levels, most patients not only regain the weight they had previously lost, but continue to gain additional weight over the subsequent several months. This has significant implications for adherence with medical therapy, particularly if the person perceives the extra weight gain to be a result of treatment.
Understanding why patients with thyrotoxicosis continue to gain weight after the restoration of a euthyroid state and investigating the regulation of appetite control in these patients has the potential to contribute to our understanding of obesity and provide insight new approaches to treatment of the hyperthyroid state.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 66838 0
Dr Marianne Elston
Address 66838 0
Department of Endocrinology
Waikato Hospital
Private Bag 3200
Hamilton 3240
Country 66838 0
New Zealand
Phone 66838 0
+6478398899
Fax 66838 0
Email 66838 0
Marianne.Elston@waikatodhb.health.nz
Contact person for public queries
Name 66839 0
Marianne Elston
Address 66839 0
Department of Endocrinology
Waikato Hospital
Private Bag 3200
Hamilton 3240
Country 66839 0
New Zealand
Phone 66839 0
+6478398899
Fax 66839 0
Email 66839 0
Marianne.Elston@waikatodhb.health.nz
Contact person for scientific queries
Name 66840 0
Marianne Elston
Address 66840 0
Department of Endocrinology
Waikato Hospital
Private Bag 3200
Hamilton 3240
Country 66840 0
New Zealand
Phone 66840 0
+6478398899
Fax 66840 0
Email 66840 0
Marianne.Elston@waikatodhb.health.nz

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.