ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12609000123246

Ethics application status

Approved

Date submitted

12/01/2009

Date registered

20/02/2009

Date last updated

7/07/2022

Date data sharing statement initially provided

7/07/2022

Date results provided

7/07/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

The effect of restorative sleep on the predisposition towards insulin resistance and diabetes: “The catch-up study”

Scientific title

The effect of restorative sleep on the predisposition towards insulin resistance and diabetes in healthy volunteers between aged 18 and 50: "The catch-up study"

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Sleep restriction

Diabetes

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Lengthened sleep - sleeping 10 hours per night from Fri until Monday morning
Restricted sleep - sleeping the same as they would during the week
Obliterating Slow Wave Sleep - using acoustic stimuli during the sleep period. Acoustic stimuli will consist of intermittent tones delivered through loudspeakers in the particpant's bedrooom. Obliterating slow wave sleep condition - sleeping 10 hours per night from Friday until Monday morning.
Duration of each condition - One weekend of testing from Friday night until Monday morning.
Each participant will only undertake 2 of the 3 conditions. They will be randomised to the conditions.
Crossover study. Duration of the 'washout' period - A minimum of 3 weeks.

Intervention code [1]

Other interventions

Comparator / control treatment

Each individual shall be their own control, as they will be tested under 2 different conditions

Control group

Active

Outcomes

Primary outcome [1]

Insulin sensitivity. It shall be tested by oral glucose tolerance test.

Timepoint [1]

After a weekend of a particular sleep condition. Immediately after waking on Monday morning.

Secondary outcome [1]

Neurocognitive tests & driving simulation. Measured by standard computerised testing

Timepoint [1]

Each day during the weekend of a particular sleep condition

Secondary outcome [2]

Blood hormone & cardiovascular markers. Blood sampling

Timepoint [2]

After a weekend of a particular sleep condition. Immediately after waking on Monday morning.

Secondary outcome [3]

Blood pressure. Measured by standard sphyngomanometry.

Timepoint [3]

Multiple measurements over the study period. At least twice a day during the weekend study period and at the screening visit.

Secondary outcome [4]

Arterial stiffness by pulse wave analysis

Timepoint [4]

After a weekend of a particular sleep condition. Immediately after waking on Monday morning.

Secondary outcome [5]

Polysomnography- sleep variables and characteristics

Timepoint [5]

Each night during the weekend of a particular sleep condition

Secondary outcome [6]

Quailty of life questionnaire

Timepoint [6]

Each weekend of a particular sleep condition

Secondary outcome [7]

Continuous glucose monitoring using subcutaneous glucose monitoring system

Timepoint [7]

For one week at home, prior to weekend study visit

Secondary outcome [8]

Sleep questionnaires

Timepoint [8]

Several times each day over the weekend of a particular sleep condition

Secondary outcome [9]

Activity questionnaire

Timepoint [9]

Each weekend of a particular sleep condition

Secondary outcome [10]

Hunger questionnaires

Timepoint [10]

Each day over the weekend of a particular sleep condition

Eligibility

Key inclusion criteria

Males between 18-50
Chronic intermittent sleep restriction

Minimum age

18 Years

Maximum age

50 Years

Sex

Males

Can healthy volunteers participate?

Yes

Key exclusion criteria

Diabetics
Any other sleep disorder
Shift workers
Time zone travel in preceding month
Psychiatric disorders or drug abuse, including alcohol
Use of sedatives or antidepressants
Chronic medical conditions likely to interfere with or influence study or the safety of the study, unless well controlled
Unable to restrict caffeine/alcohol during study duration

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)

Allocation will be by sealed opaque envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Participants will be randomised by computer generated randomisation in blocks

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

20/02/2009

Actual

20/02/2009

Date of last participant enrolment

Anticipated

Actual

7/02/2012

Date of last data collection

Anticipated

Actual

6/04/2012

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

University

Name [1]

Sydney University

Address [1]

The University of Sydney
NSW 2006
Australia

Country [1]

Australia

Primary sponsor type

Charities/Societies/Foundations

Name

Woolcock Institute of Medical Research

Address

PO Box M77
Missenden Road
NSW 2050

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

None

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South West Area Health Service - Concord Zone

Ethics committee address [1]

Concord Repatriation General Hospital, 
Hospital Road, Concord, NSW 2139

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

18/12/2008

Ethics approval number [1]

HREC 08/CRGH/184

Summary

Brief summary

As our lives get busier, it is increasingly common for people to work longer hours and get less sleep during the week. People often rely on weekends to catch-up on the sleep they have missed during the week. There has been some evidence that restricting the amount of sleep we have may predispose to developing glucose resistance and subsequent diabetes. We will also test how sleep deprivation impacts on daytime concentration and brain and memory function. This study will involve 3 study visits, with 2 being conducted over 2 weekends, at least 3 weeks apart.

Trial website

Trial related presentations / publications

Metabolic and hormonal effects of ‘catch-up’ sleep in men with chronic, repetitive, lifestyle-driven sleep restriction
Killick R, Hoyos CM, Melehan K, Dungan GC, Poh J, Liu PY
Clin Endocrinol (Oxf). 2015 Feb 14. doi: 10.1111/cen.12747. [Epub ahead of print]

Public notes

Contacts

Principal investigator

Name

A/Prof Peter Liu

Address

Woolcock Institute of Medical Research, PO Box M77, Missenden Road, NSW 2050

Country

Australia

Phone

+61291140007

Fax

peterliu@woolcock.org.au

Contact person for public queries

Name

Dr Roo Killick

Address

Woolcock Institute of Medical Research, PO Box M77, Missenden Road, NSW 2050

Country

Australia

Phone

+612 9114 0499

Fax

+612 9114 0014

rookillick@woolcock.org.au

Contact person for scientific queries

Name

A/Prof Peter Liu

Address

Woolcock Institute of Medical Research, PO Box M77, Missenden Road, NSW 2050

Country

Australia

Phone

+612 9114 0007

Fax

+612 9114 0014

peterliu@woolcock.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Individual participant underlying published results only.

When will data be available (start and end dates)?

Data will be made available upon request, after publication, with no end date determined.

Available to whom?

Data will be made available upon request, after publication and will be determined upon negotiation with researchers who provided a methodologically sound proposal.

Available for what types of analyses?

Any purpose.

How or where can data be obtained?

Secure data transfer and signed data access agreement. Contact: peterliu@woolcock.org.au

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

Source	Title	Year of Publication	DOI
Embase	Metabolic and hormonal effects of 'catch-up' sleep in men with chronic, repetitive, lifestyle-driven sleep restriction.	2015	https://dx.doi.org/10.1111/cen.12747

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically