Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000069853
Ethics application status
Approved
Date submitted
30/09/2011
Date registered
13/01/2012
Date last updated
2/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does Cabergoline prevent weight regain in people with obesity?
Scientific title
Does Cabergoline prevent weight regain in people with obesity?
Secondary ID [1] 273140 0
Nil
Universal Trial Number (UTN)
Trial acronym
Power study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 270894 0
Condition category
Condition code
Metabolic and Endocrine 279069 279069 0 0
Metabolic disorders
Diet and Nutrition 285751 285751 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cabergoline 0.5mg once weekly taken orally for two years
Intervention code [1] 269481 0
Treatment: Drugs
Intervention code [2] 284020 0
Prevention
Comparator / control treatment
matching capsule with Placebo powder
Control group
Placebo

Outcomes
Primary outcome [1] 279719 0
Prevention of weight regain after initial weight loss.
Serum prolactin concentration measurements will be measured as well as compliance.
Timepoint [1] 279719 0
6, 12, 18 and 24 months
Secondary outcome [1] 294290 0
Change in body weight, BMI, waist circumference & blood pressure. BMI - measuring weight and height and calculating waist circumference - measuring at each visit
Timepoint [1] 294290 0
3-12 monthly over 2 years.
Secondary outcome [2] 295492 0
Changes in body composition as measured by DEXA
Timepoint [2] 295492 0
start of study and at 2 year end
Secondary outcome [3] 295493 0
Changes in lipid profile, fasting glucose, insulin sensitivity as measured by HOMA, Leptin, Prolactin
Timepoint [3] 295493 0
6 monthly over 2 years ,
Secondary outcome [4] 295494 0
Weight maintenance according to dopamine receptor allele staus
Timepoint [4] 295494 0
one off blood test at randomisation
Secondary outcome [5] 295495 0
changes in resting energy expenditure, measured with cosmed pulmonary function equipment
Timepoint [5] 295495 0
at screening, randomisation and then 6 monthly for rest of study timeframe
Secondary outcome [6] 295496 0
changes in quality of life measured by questionnaire
Timepoint [6] 295496 0
6 monthly
Secondary outcome [7] 295497 0
Adverse events
e.g. dizziness, headache, nausea
Timepoint [7] 295497 0
recorded at each study visit
Secondary outcome [8] 346322 0
Changes in brain activity via EEG
Timepoint [8] 346322 0
at screening, randomisation and 3 months after starting study medication

Eligibility
Key inclusion criteria
BMI>30 (lean participants for substudy - BMI <25)
Male or female
20-65 years
pre-menopausal women must be using apropriate contraception
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
BMI <30 (lean participants for substudy - BMI >25)
Diabetes
Malignance
Cardiac disease
vascular disease
uncontrolled hypertension
psychiatric disease
other significant medical condition
women with child-bearing potential (not on appropriate contraception)
Participants using medication that could interact with cabergoline

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)
Allocation concealment
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2011
Actual
21/12/2011
Date of last participant enrolment
Anticipated
Actual
17/09/2014
Date of last data collection
Anticipated
Actual
14/10/2016
Sample size
Target
200
Accrual to date
Final
221
Recruitment outside Australia
Country [1] 3878 0
New Zealand
State/province [1] 3878 0
Otago

Funding & Sponsors
Funding source category [1] 269957 0
Government body
Name [1] 269957 0
Health Research Council
Country [1] 269957 0
New Zealand
Primary sponsor type
Government body
Name
Health Research Council
Address
PO Box 5541, Wellesley Street, Auckland 1141
Country
New Zealand
Secondary sponsor category [1] 283432 0
None
Name [1] 283432 0
Address [1] 283432 0
Country [1] 283432 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271926 0
Lower South regional ethics committee
Ethics committee address [1] 271926 0
Postal address:
PO Box 5849
Dunedin 9016

Courier address:
c/- Ministry of Health
229 Moray Place
Dunedin 9016
Ethics committee country [1] 271926 0
New Zealand
Date submitted for ethics approval [1] 271926 0
Approval date [1] 271926 0
29/11/2011
Ethics approval number [1] 271926 0
LRS/11/09/041

Summary
Brief summary
Obesity is a major public and personal global health issue. A major clinical issue in managing the obese individual is the prevention of weight regain following successful weight loss initiatives. There has been recent interest in the role of the central neurotransmitter dopamine on appetite control and energy balance, and several small studies have suggested that dopamine agonist medication could be a novel way to treat obesity. This randomised controlled trial will identify if the dopamine agonist drug Cabergoline is effective at preventing weight regain. 200 obese people will be included in the trial and followed for 2 years. A subset of these participants will complete additional procedures to measure brain activity changes alongside weight loss and study medication. If Cabergoline is successful at preventing weight regain it could have a major impact on how obesity is managed and could open up an new area of future research for this class of medication
Trial website
Trial related presentations / publications
Public notes
The substudy was added after 195 participants had been recruited for the main study to measure the effects of weight loss and Cabergoline on brain activity with EEG in approximately 35-40 participants in the Cabergoline trial. Matched lean participants under the same inclusion and exclusion criteria with the exception of different BMI criteria were also added as controls for cross-sectional analysis.

Contacts
Principal investigator
Name 33222 0
A/Prof Patrick Manning
Address 33222 0
Endocrinology Research Unit P.O. Box 913 Dunedin 9054 New Zealand
Country 33222 0
New Zealand
Phone 33222 0
+64 (03) 474 0999
Fax 33222 0
+64 (03) 470 9926
Email 33222 0
Patrick.Manning@southerndhb.govt.nz
Contact person for public queries
Name 16469 0
Ms Anne Ryalls
Address 16469 0
Endocrinology Research Unit
P.O. Box 913
Dunedin 9054
New Zealand
Country 16469 0
New Zealand
Phone 16469 0
64 (03) 474 7733
Fax 16469 0
64 (03) 470 9926
Email 16469 0
anne.ryalls@otago.ac.nz
Contact person for scientific queries
Name 7397 0
A/Prof Patrick Manning
Address 7397 0
Endocrinology Research Unit
P.O. Box 913
Dunedin 9054
New Zealand
Country 7397 0
New Zealand
Phone 7397 0
64 (03) 474 0999
Fax 7397 0
64 (03) 470 9926
Email 7397 0
Patrick.Manning@southerndhb.govt.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
SourceTitleYear of PublicationDOI
EmbasePharmaceutical interventions for weight-loss maintenance: no effect from cabergoline.2018https://dx.doi.org/10.1038/s41366-018-0165-3
EmbaseUpregulated miR-200c is associated with downregulation of the functional receptor for severe acute respiratory syndrome coronavirus 2 ACE2 in individuals with obesity.2022https://dx.doi.org/10.1038/s41366-021-00984-2
N.B. These documents automatically identified may not have been verified by the study sponsor.