Breaks in Sedentary Time and Glucose Regulation in Women (ACUTE)
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|ClinicalTrials.gov Identifier: NCT02135172|
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : December 10, 2014
|Condition or disease||Intervention/treatment||Phase|
|Impaired Glucose Tolerance||Behavioral: Sitting Behavioral: Standing Behavioral: Walking||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Does Breaking Sedentary Time Improve Glucose Regulation in Women With Impaired Glucose Tolerance? A Balanced Incomplete Block Design Study|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
During the sitting treatment condition, walking and standing will be restricted. Participants will be in a designated room with access to a computer, books/magazines throughout the day. Participants will have a cannula fitted and the first of the half-hourly blood samples will be taken (time point: -1hr). Participants will then be asked to sit quietly for 60 minutes to achieve a steady state. Following this, participants will have another blood sample taken and then be provided with a standardised mixed meal breakfast (09:00am) (time point: 0h). Blood sampling will continue at 30 minutes intervals for 3 hours following breakfast. A second, lunch meal (12:00pm), will be then be consumed over 15 minutes. Blood sampling will then continue at 30 minute intervals for 3 hours following lunch.
This is the same as the sitting condition, but participants will be asked to break their sitting time by standing close to their chair for 5 minutes, after 15 and 45 minutes of each hour following breakfast. The standing protocol will be repeated after lunch. Individuals will be asked to stand in the same position with no further instructions provided. In total, individuals will accumulate 12 bouts (60 minutes) of standing throughout the test period.
This is identical to the standing condition, but the breaks in sitting time will be punctuated with 5 minute bouts of light-intensity treadmill walking (equivalent to around 4.0km•h-1) rather than standing. In total, individuals will accumulate 12 bouts (60 minutes) of light-intensity activity throughout the test period. The light-intensity walking activity undertaken here replicates the low-grade ambulatory activity associated with everyday life.
- Glucose area under the curve [ Time Frame: 0 weeks and 2 weeks ]Glucose area under the curve (AUC); Plasma glucose will be measured using a glucose oxidase method on the Beckman Auto Analyzer (Beckman, High Wycombe, UK). Glucose profile measurements will be undertaken in the same laboratory located within the Leicester Royal Infirmary.
- Insulin area under the curve [ Time Frame: 0 weeks and 2 weeks ]
- Triacylglycerol area under the curve [ Time Frame: 0 weeks and 2 weeks ]
- Lipoprotein lipase activity [ Time Frame: 0 weeks and 2 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135172
|Leicester Diabetes Centre, Leicester General Hospital|
|Leicester, Leicestershire, United Kingdom, LE5 4PW|
|Principal Investigator:||Melanie J Davies, MD||University of Leicester|