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
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
Trial website
Trial related presentations / publications
Public notes

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
[email protected]
Contact person for public queries
Name 16469 0
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
[email protected]
Contact person for scientific queries
Name 7397 0
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
[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
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.