Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000664842
Ethics application status
Approved
Date submitted
18/06/2012
Date registered
21/06/2012
Date last updated
14/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Breaking up prolonged sitting with intermittent standing: acute effects in overweight inactive adults.
Scientific title
The acute effect of breaking up prolonged sitting with intermittent bouts of short-duration standing on postprandial glucose metabolism, lipid metabolism and vascular function in overweight/obese adults.
Secondary ID [1] 280694 0
Nil
Universal Trial Number (UTN)
Trial acronym
The STOMP (Standing To Offset the Metabolic derangement of Prolonged sitting) study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 286725 0
Overweight and obesity 286726 0
Condition category
Condition code
Metabolic and Endocrine 287025 287025 0 0
Diabetes
Diet and Nutrition 287026 287026 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The experimental condition involves a single day of prolonged sitting (total duration= 7hrs) with intermittent bouts of short-duration standing. Participants will remain seated for the initial 140min (steady state) period, after which they will consume a standardised mixed meal (50g fat, 75g carbohydrate) and will complete a 2min bout of standing every 20mins for the remaining 5 hours (total standing duration:28mins). All activities will take place in a controlled laboratory environment under the supervision of trained clinical research staff. During the condition, participants will be permitted to watch television, DVD’s or read.
In this trial, participants will complete each condition (experimental and control) in random order, with a minimum 7 day washout period between conditions.
Intervention code [1] 285106 0
Lifestyle
Comparator / control treatment
In a controlled laboratory environment, participants will complete one day (total duration=7hr) of prolonged sitting without standing breaks. Participants will sit quietly in a comfortable chair and will consume a standardised mixed meal (50g fat, 75g carbohydrate) after an intial 140min steady state period. Participants will be permitted to watch television programs, DVDs or read during the condition, and all activities will be supervised and recorded by clinical research staff.
Control group
Active

Outcomes
Primary outcome [1] 287364 0
Postprandial plasma glucose levels (mean area under the curve [AUC]). Plasma glucose concentrations will be assessed using standard testing equipment at an outsourced medical laboratory.
Timepoint [1] 287364 0
Blood glucose levels will be measured every hour for determination of the mean AUC. The mean AUC will be determined at day 7 and day 14 following study enrolment.
Primary outcome [2] 287365 0
Postprandial plasma insulin levels (mean AUC). Plasma insulin concentrations will be assessed using standard testing equipment at an outsourced medical laboratory.
Timepoint [2] 287365 0
Blood insulin levels will be measured every hour for determination of the mean AUC. The mean AUC will be determined at day 7 and day 14 following study enrolment.
Secondary outcome [1] 297993 0
Postprandial serum triglycerides (mean AUC). Plasma triglyceride concentrations will be assessed using standard testing equipment at an outsourced medical laboratory.
Timepoint [1] 297993 0
Serum triglyceride levels will be measured every hour for determination of the mean AUC. The mean AUC will be determined at day 7 and day 14 following study enrolment.
Secondary outcome [2] 297994 0
Postprandial plasma fatty acid levels (mean AUC). Plasma free fatty acid concentrations will be assessed using standard testing equipment at an outsourced medical laboratory.
Timepoint [2] 297994 0
Plasma free fatty acid levels will be measured every hour for determination of the mean AUC. The mean AUC will be determined at day 7 and day 14 following study enrolment.
Secondary outcome [3] 297995 0
Postprandial reactive oxygen metabolites (hydroperoxides). Postprandial reactive oxygen metabolites will be measured in-house using a commercially available kit (dROMs kit).
Timepoint [3] 297995 0
Serum levels of reactive oxygen species will be measured every hour for determination of the mean AUC. The mean AUC will be determined at day 7 and day 14 following study enrolment.
Secondary outcome [4] 297996 0
Measurement of endothelial function using non-invasive peripheral arterial tonometry
Timepoint [4] 297996 0
Endothelial function will be measured at 2 hours (completion of steady state period), 4 hours and 7 hours during each condition (days 7 and 14).

Eligibility
Key inclusion criteria
Inclusion criteria includes: overweight or obesity (body mass index greater than or equal to 25kg/m2 but less than or equal to 45kg/m2) and English speaking
Minimum age
45 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion is based on: of pregnancy; employment in a non-sedentary occupation (< 5 hours total sitting during the typical workday); currently watching < 3 hours of total screen (including television, computer or electronic games) time per day; regularly engaged in moderate-vigorous physical activity greater than or equal to 150min/week > 3 months; use of carbohydrate or lipid-lowering medication; greater than or equal to 5 previous vasovagal syncope episodes or epilepsy; known physical activity contraindications; major illness/injury (acute or chronic), smokers; orthostatic intolerance, and the use of aspirin or other anticoagulants.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Interested volunteers will receive written information about the study in lay terms and a full description of the inclusion/exclusion criteria. After obtaining informed consent and background information, the potential participants will be screened to confirm eligibility. Once a potential subject has been deemed eligible, the subject will be randomised to the order of experimental conditions. The method for allocation concealment is closed envelopes. The allocation information will be placed in numbered envelopes (1 allocation per envelope) by an independent researcher. After a subject has been enrolled in the study, the study co-ordinators will contact an independent staff member to ask for the sequence of experimental conditions. The independent staff member will keep a log of the date and time the envelope was opened, the envelope number, the initials and gender of the participant and the order of experimental conditions. The study co-ordinator will also keep a record of this information
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation allocation sequence will be generated using computer –generated random numbers in a balanced orthogonal design
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
18/06/2012
Actual
29/06/2012
Date of last participant enrolment
Anticipated
Actual
27/07/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285462 0
Government body
Name [1] 285462 0
National Health and Medical Research Council
Country [1] 285462 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Baker IDI Heart and Diabetes Institute
Address
75 Commercial Road, Melbourne, Victoria 3004 (Postal address: PO Box 6492, St Kilda Road Central, Victoria 8008)
Country
Australia
Secondary sponsor category [1] 284315 0
None
Name [1] 284315 0
Address [1] 284315 0
Country [1] 284315 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287477 0
The Alfred Human Research Ethics Committee
Ethics committee address [1] 287477 0
Ethics committee country [1] 287477 0
Australia
Date submitted for ethics approval [1] 287477 0
Approval date [1] 287477 0
18/05/2012
Ethics approval number [1] 287477 0
1/10/0199

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

Contacts
Principal investigator
Name 34330 0
Prof David Dunstan
Address 34330 0
Baker IDI Heart and Diabetes Institute
Level 4, 99 Commercial Rd
Melbourne VIC 3004
Country 34330 0
Australia
Phone 34330 0
+613 8532 1873
Fax 34330 0
+613 8532 1100
Email 34330 0
[email protected]
Contact person for public queries
Name 17577 0
Dr Robyn Larsen
Address 17577 0
Baker IDI Heart and Diabetes Institute
Level 4, 99 Commercial Road, Melbourne, Victoria, 3004
Country 17577 0
Australia
Phone 17577 0
+613 8532 1859
Fax 17577 0
+613 8532 1100
Email 17577 0
[email protected]
Contact person for scientific queries
Name 8505 0
Dr Alicia Thorp
Address 8505 0
Baker IDI Heart and Diabetes Institute
Level 4, 99 Commercial Road, Melbourne, Victoria, 3004
Country 8505 0
Australia
Phone 8505 0
+613 8532 1854
Fax 8505 0
+613 8532 1100
Email 8505 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.