Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000239268
Ethics application status
Approved
Date submitted
18/01/2018
Date registered
14/02/2018
Date last updated
23/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Do regular activity breaks from prolonged sitting improve the cardiometabolic profile of women with polycystic ovary syndrome? The PCOS BREAKS Study
Scientific title
Do regular activity breaks from prolonged sitting improve the cardiometabolic profile of women with polycystic ovary syndrome? The PCOS BREAKS Study
Secondary ID [1] 293813 0
None
Universal Trial Number (UTN)
Trial acronym
PCOS BREAKS study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Impaired glucose response 306226 0
Polycystic ovary syndrome 306227 0
Cardiovascular risk factors 306228 0
Condition category
Condition code
Metabolic and Endocrine 305330 305330 0 0
Other endocrine disorders
Reproductive Health and Childbirth 305405 305405 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised, acute crossover trial involving two conditions will be conducted in 22 overweight/obese women with diagnosed PCOS in a controlled clinical environment. The two conditions will include;
1) 3-hours of uninterrupted sitting (SIT); and
2) 3-hours of sitting with 3-min simple resistance activity breaks every 30 minutes (BREAKS).

Participants must be of reproductive age (18-45 years), have a BMI between 25-35 kg/m2, medically diagnosed with PCOS (clinician confirmed) and have no existing injuries or dietary allergies.

Three days prior to beginning the two conditions, participants will visit the Baker and be fitted with: a continuous glucose monitoring system ([CGM], a small device that records glucose levels every 5 minutes); an ActivPal (fitted on the right thigh) and an ActiGraph watch (fitted on the right wrist). Participants will be asked to wear all three monitors 24 hours/day (including sleeping and showering) until the morning after completing the condition days. While wearing the monitors, participants will be asked to complete a brief activity log and sleep questionnaire (approximate 2-3 minutes to complete) the morning of every day the monitors are worn.

In the 48 hours prior to both condition days, participants will be asked to refrain from consuming alcohol and caffeine, and from participating in any moderate to vigorous physical activity (exercise). The day before the condition day, participants will be asked to record all food and beverages that they consume in a food log diary. They will then be asked to consume this same diet the day before the last condition day. The night prior to each condition day, participants will consume a standardised dinner (provided by the researchers). Participants will also be asked to go to bed at their normal bedtime.

The morning of both condition days, participants will arrive in a fasting state and a cannula will be inserted into a vein in their left arm. During the 1-hr steady state, participants will have a fasted blood sample taken, blood pressure measure taken, a ‘Flow-Mediated Dilatation (FMD) test’ (a non-invasive test that measures the blood flow in the leg) taken and asked to complete a fatigue questionnaire. Throughout the 3-hr trial, blood samples will be taken every 30 minutes, blood pressure every hour and three additional FMD test (between 0.5-1 hour, 1.5-2.0h and post 3.0h). Two additional tests examining fatigue levels will also be completed at 1.5 hours and immediately post trial (prior to the last FMD test). On commencement of the trial, participants will be asked to record all food and drinks consumed for the rest of the day, and asked to repeat this same diet for condition day 2. They will also be asked to continue to wear the three monitors until the following morning and post them back using the replied paid envelope.

Participants will return to complete the last condition day following a 7-day wash out period and after adhering to the same 48-hour restrictive period as described above (in total, 9 days). After completing the last condition day, participants will be asked to repeat the same diet as condition day 1 and to wear the monitors all three monitors until the following morning (and post back using the replied paid envelope). Where possible the two condition days will be performed in the follicular phase of the participant’s menstrual cycle.
Intervention code [1] 300066 0
Lifestyle
Comparator / control treatment
3-hours of uninterrupted sitting will act as the control.
Control group
Active

Outcomes
Primary outcome [1] 304485 0
Glucose and insulin incremental area under the curve (iAUC; calculated using the trapezoidal method) via blood samples
Timepoint [1] 304485 0
Eight blood samples collected at -1.0h, 0h, 0.5h, 1.0h, 1.5h, 2.0h, 2.5h, 3.0h for each condition *To note the -1.0h to 0h is deemed the 'steady state' period. Blood samples at 0h will be collected just prior to participants consuming the meal.
Secondary outcome [1] 342116 0
Changes in pre- and post- total testosterone levels measured via venipuncture in a serum assay
Timepoint [1] 342116 0
Two plasma samples collected at 0h and 3.0h for each condition

*To note the 0h measurement (e.g. baseline) is collected just after the 1-hour of steady state has been reached and just prior to the participant consuming the standardised meal.
Secondary outcome [2] 342322 0
Changes in pre- and post- sex hormone binding globulin (SHBG) levels measured via venipuncture
Timepoint [2] 342322 0
Two plasma samples collected at 0h and 3.0h for each condition

*To note the 0h measurement (e.g. baseline) is collected just after the 1-hour of steady state has been reached and just prior to the participant consuming the standardised meal.
Secondary outcome [3] 343062 0
Changes in blood pressure
Timepoint [3] 343062 0
Five blood pressure measures will be taken at -1.0, 0h, 1.0h, 2.0h and 3.0h for each condition.

*To note the 0h measurement (e.g. baseline) is collected just after the 1-hour of steady state has been reached and just prior to the participant consuming the standardised meal.
Secondary outcome [4] 343063 0
Changes in endothelial function (measured using flow-mediated dilatation [FMD])
Timepoint [4] 343063 0
Four FMD measures will be taken at -0.5h, 1.0h, 2.0h and 3.0h for each condition.

Secondary outcome [5] 343064 0
Self-reported fatigue/alertness (assessed by visual analogue scale of fatigue, 18 qs)
Timepoint [5] 343064 0
Three fatigue/alertness questionnaires will be completed at -1.0h (baseline), 1.5h (during) and 3.0h (post) for each condition.
Secondary outcome [6] 346777 0
Continuous glucose measured every 5 mins from the start of the trial to the following morning prior to the participant consuming breakfast.
Timepoint [6] 346777 0
Glucose monitoring has been extended to 24 hours to capture any post trial effects on glucose

Eligibility
Key inclusion criteria
Females of reproductive age (18 - 45 years)
BMI between 18.5-40 kg/m2
Medically diagnosed with Polycystic Ovarian Syndrome (PCOS)
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
On any glucose-lowering medications that may affect glucose metabolism.
Existing injuries or dietary allergies that may restrict full participation in all trial conditions.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power calculations are based on previous work where 22 paired observations (accounting for 20% attrition) will achieve 90% power to detect the smallest expected effect size in glucose (Cohen’s d = 0.84) between conditions.

Generalized estimating equations will be used to examine the differential effects of the trial conditions on glucose iAUC, and insulin and antigen levels, with all models adjusting for age, BMI, baseline fasting glucose and period effects.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2018
Actual
Date of last participant enrolment
Anticipated
1/12/2018
Actual
Date of last data collection
Anticipated
31/12/2018
Actual
Sample size
Target
22
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9820 0
Baker Heart and Diabetes Institute - Melbourne
Recruitment postcode(s) [1] 18601 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 298427 0
Government body
Name [1] 298427 0
National Health and Medical Research Council, Centre for Research Excellence in PCOS
Country [1] 298427 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Baker Heart and Diabetes Institute
Address
99 Commercial Rd
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 297568 0
None
Name [1] 297568 0
Address [1] 297568 0
Country [1] 297568 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299423 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 299423 0
Ethics committee country [1] 299423 0
Australia
Date submitted for ethics approval [1] 299423 0
28/02/2018
Approval date [1] 299423 0
30/04/2018
Ethics approval number [1] 299423 0

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

Contacts
Principal investigator
Name 80354 0
Prof David Dunstan
Address 80354 0
Baker Heart and Diabetes Institute
Level 4, 99 Commercial Road,
Melbourne Vic 3004 Australia
Country 80354 0
Australia
Phone 80354 0
+61 385321873
Fax 80354 0
Email 80354 0
Change of PI
Contact person for public queries
Name 80355 0
Elly Fletcher
Address 80355 0
Baker Heart and Diabetes Institute
Level 4, 99 Commercial Road,
Melbourne Vic 3004 Australia
Country 80355 0
Australia
Phone 80355 0
+61 3 8532 1834
Fax 80355 0
Email 80355 0
[email protected]
Contact person for scientific queries
Name 80356 0
Elly Fletcher
Address 80356 0
Baker Heart and Diabetes Institute
Level 4, 99 Commercial Road,
Melbourne Vic 3004 Australia
Country 80356 0
Australia
Phone 80356 0
+61 3 8532 1834
Fax 80356 0
Email 80356 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
No additional documents have been identified.