Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001112651
Ethics application status
Approved
Date submitted
7/10/2014
Date registered
20/10/2014
Date last updated
21/03/2022
Date data sharing statement initially provided
21/03/2022
Date results provided
21/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of spironolactone on brown fat activity in adult humans
Scientific title
Effect of spironolactone on brown fat activity in healthy adult humans
Secondary ID [1] 285442 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 293205 0
Condition category
Condition code
Diet and Nutrition 293478 293478 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
randomised double-blind placebo-controlled cross-over study of treatment with oral spironolactone 100mg daily for 2 weeks
and 2 weeks wash-out period.
The participants will return the drug bottles after each treatment period.
Intervention code [1] 290375 0
Treatment: Drugs
Comparator / control treatment
Each participant will have placebo tablet once daily for 2 weeks as well as spironolactone 100mg once daily for 2 weeks in the random order
Control group
Placebo

Outcomes
Primary outcome [1] 293301 0
Brown Fat volume changes on 18FDG-PET-CT scan
Timepoint [1] 293301 0
after two weeks of placebo and after two weeks of spironolactone
Primary outcome [2] 293353 0
Brown fat activity changes on PET-CT
Timepoint [2] 293353 0
after two weeks of placebo and after two weeks of spironolactone
Secondary outcome [1] 310766 0
Changes in resting energy expenditure using indirect calorimetry
Timepoint [1] 310766 0
after two weeks of placebo and after two weeks of spironolactone
Secondary outcome [2] 310893 0
Changes in diet-induced thermogenesis using indirect calorimetry
Timepoint [2] 310893 0
after two weeks of placebo and after two weeks of spironolactone

Eligibility
Key inclusion criteria
healthy adults aged 18-50 years old, BMI<35
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnancy
eGFR <60

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
double-blind random sequence of allocation with allocation concealment will be used, ie. Blinded investigator will randomly select a pre-packed, numbered envelope containing two bottles of study medications (one bottle containing active medication, one bottle containing placebo which are marked as bottle A or bottle B and packed by a research staff not involved in this study), and this will be allocated to the participant and recorded in study medication logs.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
block randomisation (half of the group getting placebo first, half of the group getting active medication first) was used in packing by non-investigator, followed by random allocation by a blinded investigator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
According to a study, a sample size of 5 is required to show a significance at 0.05 with 80% power to detect change in BAT activity. 8-9 of 12 subjects is anticipated to be BAT positive, which will allow the effect of drug intervention to be examined. The sample size was further adjusted for a drop-out rate of 10% at each time point.
Paired t-test will be used to analyse the changes in study outcomes at each time point mentioned.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/01/2015
Actual
1/04/2016
Date of last participant enrolment
Anticipated
30/06/2017
Actual
28/10/2016
Date of last data collection
Anticipated
Actual
30/11/2016
Sample size
Target
12
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 3037 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 8802 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 290059 0
Charities/Societies/Foundations
Name [1] 290059 0
Princess Alexandra Hospital Research Support Scheme
Country [1] 290059 0
Australia
Primary sponsor type
Individual
Name
Professor Ken Ho
Address
Level 7, Translational Research Institute
37 Kent Street,
Woolloongabba, Queensland 4102
Country
Australia
Secondary sponsor category [1] 288748 0
Individual
Name [1] 288748 0
Dr Moe Thuzar
Address [1] 288748 0
Level 5, Translational Research Institute
37 Kent Street,
Woolloongabba, Qld 4102
Country [1] 288748 0
Australia
Other collaborator category [1] 278175 0
Individual
Name [1] 278175 0
A/Professor Michael Stowasser
Address [1] 278175 0
Hypertension unit,
Princess Alexandra Hospital
199 Ipswich Road,
Woolloongabba, Qld 4102
Country [1] 278175 0
Australia
Other collaborator category [2] 278176 0
Individual
Name [2] 278176 0
Dr Phillip Law
Address [2] 278176 0
Department of Radiology/Molecular Imaging
Princess Alexandra Hospital
199 Ipswich Road,
Woolloongabba, Qld 4102
Country [2] 278176 0
Australia
Other collaborator category [3] 278177 0
Individual
Name [3] 278177 0
Dr Goce Dimeski
Address [3] 278177 0
Department of Chemical Pathology
Princess Alexandra Hospital
199 Ipswich Road,
Woolloongabba, Qld 4102
Country [3] 278177 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291763 0
Metro South Health Service District Human Research Ethics Committee
Ethics committee address [1] 291763 0
Ethics committee country [1] 291763 0
Australia
Date submitted for ethics approval [1] 291763 0
13/10/2014
Approval date [1] 291763 0
23/01/2015
Ethics approval number [1] 291763 0

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

Contacts
Principal investigator
Name 51866 0
Prof Ken Ho
Address 51866 0
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba, Queensland 4102
Country 51866 0
Australia
Phone 51866 0
+61 7 3443 8066
Fax 51866 0
Email 51866 0
[email protected]
Contact person for public queries
Name 51867 0
Moe Thuzar
Address 51867 0
Level 5, Translational Research Institute
37 Kent Street
Woolloongabba, Queensland 4102
Country 51867 0
Australia
Phone 51867 0
+61 7 3443 7944
Fax 51867 0
Email 51867 0
[email protected]
Contact person for scientific queries
Name 51868 0
Ken Ho
Address 51868 0
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba, Queensland 4102
Country 51868 0
Australia
Phone 51868 0
+61 7 3443 8066
Fax 51868 0
Email 51868 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.