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Trial registered on ANZCTR


Trial ID
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
Scientific title
Dexamphetamine to treat obesity complicated by diabetes or obstructive sleep apnoea
Secondary ID [1] 282611 0
Nil
Universal Trial Number (UTN)
U1111-1143-9788
Trial acronym
Dexamphetamine-obesity study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity
289304 0
Obstructive sleep apnoea 289305 0
Type 2 diabetes 289306 0
Condition category
Condition code
Diet and Nutrition 289639 289639 0 0
Obesity
Respiratory 289640 289640 0 0
Sleep apnoea
Metabolic and Endocrine 289641 289641 0 0
Diabetes

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 287282 0
Treatment: Drugs
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289722 0
Weight loss
Difference between weight at baseline and weight at 6 months. Weight measured using electronic scales
Timepoint [1] 289722 0
After 6 months of treatment
Primary outcome [2] 289723 0
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.
Timepoint [2] 289723 0
After 6 months of treatment
Primary outcome [3] 289724 0
Change in insulin requirement
Participants will be asked their daily insulin requirement at baseline and at 6 months and the change calculated
Timepoint [3] 289724 0
After 6 months of treatment
Secondary outcome [1] 303235 0
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
Timepoint [1] 303235 0
12 months
Secondary outcome [2] 303236 0
Changes in regular medications
Participants will be asked their daily regular medications at baseline and at 6 months and the changes documented
Timepoint [2] 303236 0
At 6 months

Eligibility
Key inclusion criteria
BMI greater than 30
and either obstructive sleep apnoea on PAP
or Type 2 diabetes mellitus
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Clinical assessment for suitability, including cardiac investigations
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Longitudinal changes assessed in relation to predictive variables using linear modelling

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1120 0
Nepean Hospital - Kingswood

Funding & Sponsors
Funding source category [1] 287501 0
Self funded/Unfunded
Name [1] 287501 0
Address [1] 287501 0
Country [1] 287501 0
Primary sponsor type
Hospital
Name
Nepean Hospital
Address
Nepean Hospital
PO Box 63
Penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 286239 0
None
Name [1] 286239 0
Address [1] 286239 0
Country [1] 286239 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289414 0
Nepean Blue Mountains Local Health District Human Research Ethics Committee
Ethics committee address [1] 289414 0
Nepean Hospital
PO Box 63
Penrith NSW 2751
Ethics committee country [1] 289414 0
Australia
Date submitted for ethics approval [1] 289414 0
Approval date [1] 289414 0
12/04/2012
Ethics approval number [1] 289414 0
12/3 - HREC/12/Nepean/8

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40486 0
Dr Alison Poulton
Address 40486 0
Sydney Medical School Nepean
Nepean Hospital
PO Box 63
Penrith
NSW 2751
Country 40486 0
Australia
Phone 40486 0
+61 247 343363
Fax 40486 0
Email 40486 0
alison.poulton@sydney.edu.au
Contact person for public queries
Name 40487 0
Dr Alison Poulton
Address 40487 0
Sydney Medical School Nepean
Nepean Hospital
PO Box 63
Penrith
NSW 2751
Country 40487 0
Australia
Phone 40487 0
+61 247 343363
Fax 40487 0
Email 40487 0
alison.poulton@sydney.edu.au
Contact person for scientific queries
Name 40488 0
Dr Alison Poulton
Address 40488 0
Sydney Medical School Nepean
Nepean Hospital
PO Box 63
Penrith
NSW 2751
Country 40488 0
Australia
Phone 40488 0
+61 247 343363
Fax 40488 0
Email 40488 0
alison.poulton@sydney.edu.au