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Trial registered on ANZCTR
Registration number
ACTRN12613000727741
Ethics application status
Approved
Date submitted
12/06/2013
Date registered
2/07/2013
Date last updated
12/01/2016
Type of registration
Prospectively registered
Titles & IDs
Public title
A pilot study to investigate the use of dexamphetamine to treat obesity complicated by diabetes or obstructive sleep apnoea
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Scientific title
Dexamphetamine to treat obesity complicated by diabetes or obstructive sleep apnoea
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Secondary ID [1]
282611
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Nil
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Universal Trial Number (UTN)
U1111-1143-9788
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Trial acronym
Dexamphetamine-obesity study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obesity
289304
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Obstructive sleep apnoea
289305
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Type 2 diabetes
289306
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Condition category
Condition code
Diet and Nutrition
289639
289639
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0
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Obesity
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Respiratory
289640
289640
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0
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Sleep apnoea
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Metabolic and Endocrine
289641
289641
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
6 months treatment with oral dexamphetamine, starting at 5mg twice daily and increased if tolerated to 30mg twice daily in weekly increments of 5mg per dose. Compliance will be monitored by keeping track of the amount of medication prescribed and the expected number of tablets used per day.
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Intervention code [1]
287282
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Treatment: Drugs
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Comparator / control treatment
Not applicable
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Weight loss
Difference between weight at baseline and weight at 6 months. Weight measured using electronic scales
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Assessment method [1]
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Timepoint [1]
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After 6 months of treatment
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Primary outcome [2]
289723
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Change in apnoea-hypopnoea index (AHI)
The AHI is defined as the number of apnoeas or hypopnoeas occurring during 1 hour of sleep. (ie the units are events/hour sleep)
An apnoea is defined as an event if there is a 90% reduction in airflow at baseline lasting for at least 10 sec. A Hypopnoea is 30% reduction in airflow at baseline lasting for at least 10 sec with a 3% desaturation of oxygen.
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Assessment method [2]
289723
0
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Timepoint [2]
289723
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After 6 months of treatment
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Primary outcome [3]
289724
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Change in insulin requirement
Participants will be asked their daily insulin requirement at baseline and at 6 months and the change calculated
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Assessment method [3]
289724
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Timepoint [3]
289724
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After 6 months of treatment
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Secondary outcome [1]
303235
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Change in weight after ceasing treatment
Difference between weight at 6 months on ceasing treatment and weight at 12 months. Weight measured using electronic scales
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Assessment method [1]
303235
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Timepoint [1]
303235
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12 months
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Secondary outcome [2]
303236
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Changes in regular medications
Participants will be asked their daily regular medications at baseline and at 6 months and the changes documented
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Assessment method [2]
303236
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Timepoint [2]
303236
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At 6 months
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Eligibility
Key inclusion criteria
BMI greater than 30
and either obstructive sleep apnoea on PAP
or Type 2 diabetes mellitus
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
History of addiction to illicit drugs, uncontrolled hypertension greater than 140/90, symptomatic ischaemic heart disease, significant kidney or liver disease, uncontrolled epilepsy, weight change of more than 3kg the past 3 months, breastfeeding, pregnant or planning pregnancy, history of bariatric surgery, current depression or other psychiatric illness, current treatment with psychotropic medication, systemic glucocorticoids or medication for weight loss (eg orlistat), family history of sudden death from cardiac causes, hypersensitivity to dexamphetamine or any components of the tablet.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Clinical assessment for suitability, including cardiac investigations
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
This study involves a predetermined duration of treatment: 6 months. Therefore the endpoint is completion of 6 months from commencement of treatment
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Longitudinal changes assessed in relation to predictive variables using linear modelling
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
9/08/2016
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Actual
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Date of last participant enrolment
Anticipated
13/12/2017
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
24
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
1120
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Nepean Hospital - Kingswood
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Funding & Sponsors
Funding source category [1]
287501
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Self funded/Unfunded
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Name [1]
287501
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Address [1]
287501
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Country [1]
287501
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Primary sponsor type
Hospital
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Name
Nepean Hospital
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Address
Nepean Hospital
PO Box 63
Penrith NSW 2751
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Country
Australia
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Secondary sponsor category [1]
286239
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None
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Name [1]
286239
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Address [1]
286239
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Country [1]
286239
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289414
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Nepean Blue Mountains Local Health District Human Research Ethics Committee
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Ethics committee address [1]
289414
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Nepean Hospital
PO Box 63
Penrith NSW 2751
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Ethics committee country [1]
289414
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Australia
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Date submitted for ethics approval [1]
289414
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Approval date [1]
289414
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12/04/2012
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Ethics approval number [1]
289414
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12/3 - HREC/12/Nepean/8
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Summary
Brief summary
The long-term aim of this research is to develop a safe, effective and economical program that uses dexamphetamine to assist individuals in the establishment of a healthy pattern of diet and exercise for the treatment of obesity and maintenance of weight control.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Alison Poulton
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Address
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Sydney Medical School Nepean
Nepean Hospital
PO Box 63
Penrith
NSW 2751
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Country
40486
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Australia
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Phone
40486
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+61 247 343363
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Fax
40486
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Email
40486
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[email protected]
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Contact person for public queries
Name
40487
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Dr Alison Poulton
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Address
40487
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Sydney Medical School Nepean
Nepean Hospital
PO Box 63
Penrith
NSW 2751
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Country
40487
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Australia
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Phone
40487
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+61 247 343363
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Fax
40487
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Email
40487
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[email protected]
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Contact person for scientific queries
Name
40488
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Dr Alison Poulton
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Address
40488
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Sydney Medical School Nepean
Nepean Hospital
PO Box 63
Penrith
NSW 2751
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Country
40488
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Australia
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Phone
40488
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+61 247 343363
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Fax
40488
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Email
40488
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[email protected]
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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.
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