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Trial registered on ANZCTR


Registration number
ACTRN12612000492853
Ethics application status
Approved
Date submitted
7/05/2012
Date registered
7/05/2012
Date last updated
3/07/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Shift Work on Post Prandial Dysmetabolism
Scientific title
Effect of Shift Work on Post Prandial Dysmetabolism in healthy volunteers: a pilot study
Secondary ID [1] 280446 0
nil
Universal Trial Number (UTN)
U1111-1130-4616
Trial acronym
PPD study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
This study aims to explore the impact of an imposed de-synchronisation between circadian rhythms, sleep cycles and eating patterns - as would occur during a rotation between day and night work, on postprandial dysmetabolism. 286420 0
Condition category
Condition code
Metabolic and Endocrine 286671 286671 0 0
Normal metabolism and endocrine development and function
Cardiovascular 286672 286672 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this study we will implement a protocol that simulates an industry standard 12-hour work shift (with basic computer based office work tasks).

Participants will be randomised initially, to either shift work condition (night shift first or day shift first). Once the first shift is complete there will then be a two week wash out period. Then the second shift will begin.

Both works shifts consist of 3 days of 12 hours (36 hour work week).
Intervention code [1] 284804 0
Behaviour
Intervention code [2] 284805 0
Lifestyle
Comparator / control treatment
This is a cross over study. Subjects will act as their own controls during the simulated day shift and will be compared to their performance during the simulated nightshift.
Control group
Active

Outcomes
Primary outcome [1] 287074 0
Blood samples will be taken from an intravenous catheter to determine triglycerides, Free Fatty Acids, Glucose, Insulin and Cortisol levels
Timepoint [1] 287074 0
Every hour on Day 1 and 3 of each shift
Primary outcome [2] 287075 0
Blood glucose levels will also be monitored by a Continuous glucose monitoring device
Timepoint [2] 287075 0
Readings will be recorded every hour for all 3 days of each shift.
Secondary outcome [1] 297326 0
Neurocognitive performance on the AusEd driving simulator
Timepoint [1] 297326 0
Before and after every simulated work shift (for both the night and day shift conditions)

Eligibility
Key inclusion criteria
Healthy volunteers, with no shift work experience
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Hypertriglycerdemia (TAG > 4mmol/dl), Impaired fasting glucose (>5.6 mmol/dL), Current shift worker, Moderate or worse OSA (AHI>15) or treated OSA, history of cardiovascular, renal or metabolic disease including stroke, coronary heart disease, kidney disease and diabetes (Type 1&2), other co-morbid sleep conditions (insomnia, sleep phase syndromes, narcolepsy etc) neurological or psychiatric disease that the investigators consider will alter normal sleep patterns.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Each subject will be randomised to the Day or Night Roster first and then crossover to the opposing roster with an intervening 2 week washout. Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be done on computer via a random number sequence generator
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/06/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
5
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285207 0
Government body
Name [1] 285207 0
Centre for Integrated Research and Understanding of Sleep (CIRUS) seed funding for Research
Country [1] 285207 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney
NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 284079 0
Charities/Societies/Foundations
Name [1] 284079 0
Woolcock Institute of Medical Research
Address [1] 284079 0
431 Glebe Point Road, Glebe NSW, 2037
Country [1] 284079 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287207 0
Sydney Local Health District Ethics Review Committee
Ethics committee address [1] 287207 0
Ethics committee country [1] 287207 0
Australia
Date submitted for ethics approval [1] 287207 0
Approval date [1] 287207 0
02/06/2011
Ethics approval number [1] 287207 0
HREC/11/RPAH/186

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34143 0
Address 34143 0
Country 34143 0
Phone 34143 0
Fax 34143 0
Email 34143 0
Contact person for public queries
Name 17390 0
Christopher Miller
Address 17390 0
Woolcock Institute of Medical Research
431 Glebe Point Road,
Glebe
Sydney
NSW 2037
Country 17390 0
Australia
Phone 17390 0
+61 (2) 9114 0451
Fax 17390 0
+ 61 2 9114 0014
Email 17390 0
chris.miller@sydney.edu.au
Contact person for scientific queries
Name 8318 0
Craig Phillips
Address 8318 0
Woolcock Institute of Medical Research
431 Glebe Point Road,
Glebe
Sydney
NSW 2037
Country 8318 0
Australia
Phone 8318 0
+61 (2) 9114 0448
Fax 8318 0
+61 (2) 9114 0014
Email 8318 0
craig.phillips@sydney.edu.au

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.