Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614001116617
Ethics application status
Not yet submitted
Date submitted
10/10/2014
Date registered
22/10/2014
Date last updated
22/10/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of spironolactone on human brown fat in patients with primary aldosteronism
Scientific title
Effect of spironolactone on human brown fat in patients with primary aldosteronism
Secondary ID [1] 285483 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary aldosteronism 293268 0
Obesity 293269 0
Condition category
Condition code
Diet and Nutrition 293535 293535 0 0
Obesity
Metabolic and Endocrine 293582 293582 0 0
Other metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Primary aldosteronism who will be treated with at least 4 weeks of oral spironolactone.
The dose, titration and total duration of treatment will be at the discretion of the treating physician (ie. no influence by the study).
Brown fat activity (on PET-CT scan) and energy expenditures (using indirect calorimetry) will be assessed before and at least 4 weeks of treatment (but no more than 8 weeks)
Intervention code [1] 290422 0
Not applicable
Comparator / control treatment
Each participant will be assessed before and at least 4 weeks after treatment with sprionolactone (but no more than 8 weeks)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293357 0
Brown fat volume changes on 18FDG-PET-CT scan
Timepoint [1] 293357 0
before and at least 4 weeks after treatment with spironolactone (but no more than 8 weeks after treatment commencement)
Primary outcome [2] 293358 0
Brown fat activity changes on 18-FDG-PET-CT scan
Timepoint [2] 293358 0
before and at least 4 weeks after treatment with sprionolactone (but no more than 8 weeks after treatment commencement)
Secondary outcome [1] 310837 0
changes in resting energy expenditure using indirect calorimetry
Timepoint [1] 310837 0
before and at least 4 weeks after treatment with spironolactone (but no more than 8 weeks after treatment commencement)
Secondary outcome [2] 310933 0
changes in diet-induced thermogenesis using indirect calorimetry
Timepoint [2] 310933 0
before and at least 4 weeks after treatment with spironolactone (but no more than 8 weeks after treatment commencement)

Eligibility
Key inclusion criteria
Subjects with primary aldosteronism who will be treated with at least 4 weeks of spironolactone
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/01/2015
Actual
Date of last participant enrolment
Anticipated
30/06/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 3045 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 8818 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 290085 0
Charities/Societies/Foundations
Name [1] 290085 0
Princess Alexandra Hospital Research Support Scheme/Research Foundation
Country [1] 290085 0
Australia
Primary sponsor type
Individual
Name
Professor Ken Ho
Address
Level 7, Translational Research Institute
37 Kent Street,
Woolloongabba, Qld 4102
Country
Australia
Secondary sponsor category [1] 288783 0
Individual
Name [1] 288783 0
Dr Moe Thuzar
Address [1] 288783 0
Level 5, Translational Research Institute
37 Kent Street,
Woolloongabba, Qld 4102
Country [1] 288783 0
Australia
Other collaborator category [1] 278191 0
Individual
Name [1] 278191 0
A/Professor Michael Stowasser
Address [1] 278191 0
Hypertension Unit,
Princess Alexandra Hospita
199 Ipswich Road,
Woolloongabba, Qld 4102
Country [1] 278191 0
Australia
Other collaborator category [2] 278192 0
Individual
Name [2] 278192 0
Dr Phillip Law
Address [2] 278192 0
Department of Radiology/Molecular Imaging
Princess Alexandra Hospital
199 Ipswich Road,
Woolloongabba, Qld 4102
Country [2] 278192 0
Australia
Other collaborator category [3] 278193 0
Individual
Name [3] 278193 0
Dr Goce Dimeski
Address [3] 278193 0
Department of Chemical Pathology
Princess Alexandra Hospital
199 Ipswich Road,
Woolloongabba, Qld 4102
Country [3] 278193 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 291791 0
Metro South Health Service District Human Research Ethics Committee
Ethics committee address [1] 291791 0
Level 7, Translational Research Institute
37 Kent Street,
Woolloongabba, Qld 4102
Ethics committee country [1] 291791 0
Australia
Date submitted for ethics approval [1] 291791 0
13/10/2014
Approval date [1] 291791 0
Ethics approval number [1] 291791 0

Summary
Brief summary
Brown Fat, unlike ordinary 'white fat', functions like generators, burning fat to produce heat and dissipate energy. Brown fat protects animals against cold and from developing obesity. In humans, it was previously believed
that brown fat disappears after infancy. However, research including our own has shown that brown fat is present in most if not all adult humans and is located mainly around the neck. Brown fat activity in humans is detected by a PET scan based on uptake of glucose that is tagged with a
small amount of radioactivity. This is a widely used diagnostic method in medicine.
Brown fat is more abundant in lean than in obese individuals. Stimulating its activity may be a simple way of controlling body weight in humans. Apart from the cold exposure, very little is known about what regulates
brown fat in humans. Our research aims to identify factors that regulate brown fat in humans.
Aldosterone is a mineralocorticoid hormone produced from the adrenal glands. In animals, it was found that aldosterone suppresses the activity of brown fat and blocking aldosterone action by a medication called spironolactone increases brown fat activity.
In this study, we will study in humans whether spironolactone reactivates brown fat activity in subjects with primary aldosteronism and whether the changes in brown fat activity is associated with changes in energy expenditures.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52050 0
Prof Ken Ho
Address 52050 0
Level 7, Translational Research Institute
37 Kent street,
Woolloongabba, Qld 4102
Country 52050 0
Australia
Phone 52050 0
+61 7 3443 8066
Fax 52050 0
Email 52050 0
[email protected]
Contact person for public queries
Name 52051 0
Moe Thuzar
Address 52051 0
Level 5, Translational Research Institute
37 Kent street,
Woolloongabba, Qld 4102
Country 52051 0
Australia
Phone 52051 0
+61 7 3443 7944
Fax 52051 0
Email 52051 0
[email protected]
Contact person for scientific queries
Name 52052 0
Ken Ho
Address 52052 0
Level 7, Translational Research Institute
37 Kent street,
Woolloongabba, Qld 4102
Country 52052 0
Australia
Phone 52052 0
+61 7 3443 8066
Fax 52052 0
Email 52052 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.