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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
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
National Health Service, United Kingdom
Information provided by (Responsible Party):
University of Leicester

Tracking Information
First Submitted Date  ICMJE January 2, 2014
First Posted Date  ICMJE May 9, 2014
Last Update Posted Date December 10, 2014
Study Start Date  ICMJE October 2013
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Breaks in Sedentary Time and Glucose Regulation in Women
Official Title  ICMJE Does Breaking Sedentary Time Improve Glucose Regulation in Women With Impaired Glucose Tolerance? A Balanced Incomplete Block Design Study
Brief Summary The number of people diagnosed with Type 2 diabetes (T2DM) is increasing rapidly and about 2.9 million people in the UK currently have diabetes. There is increasing evidence suggesting that prolonged sedentary time may actually increase the risk of diabetes and other chronic diseases. Importantly, adults can meet public health guidelines on physical activity (150 minutes of moderate activity per week), but if they still sit for prolonged periods, their metabolic health is compromised. Going from sitting to standing and carrying out light-intensity activities (such as casual walking) may reduce diabetes risk. However, no one has investigated the effect of standing and walking on markers of cardio-metabolic markers in individuals with a high risk of T2DM. Therefore, the aim is to find out whether reducing the amount of time people spend sitting and replacing it with standing and light intensity activity (walking) reduces glucose, insulin and triglyceride levels, therefore reducing the risk of diabetes.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Impaired Glucose Tolerance
Intervention  ICMJE
  • Behavioral: Sitting
  • Behavioral: Standing
  • Behavioral: Walking
Study Arms  ICMJE
  • Experimental: Sitting
    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.
    Intervention: Behavioral: Sitting
  • Experimental: Standing
    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.
    Intervention: Behavioral: Standing
  • Experimental: Walking
    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.
    Intervention: Behavioral: Walking
Publications * Henson J, Davies MJ, Bodicoat DH, Edwardson CL, Gill JM, Stensel DJ, Tolfrey K, Dunstan DW, Khunti K, Yates T. Breaking Up Prolonged Sitting With Standing or Walking Attenuates the Postprandial Metabolic Response in Postmenopausal Women: A Randomized Acute Study. Diabetes Care. 2016 Jan;39(1):130-8. doi: 10.2337/dc15-1240. Epub 2015 Dec 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 9, 2014)
22
Original Estimated Enrollment  ICMJE
 (submitted: May 6, 2014)
30
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Sedentary
  • Overweight or obese (BMI>25kg/m2)
  • Post menopausal
  • Previous diagnosis of impaired glucose tolerance

Exclusion Criteria:

  • Regular purposeful exercise (≥150 minutes of MVPA per week)
  • Physical condition which limits full participation in the study
  • Active psychotic illness or other significant illness which, in the view of the investigators, would prevent full participation
  • Inability to communicate in spoken English
  • Steroid use
  • Known Type 2 Diabetes
  • Pregnancy
  • Male
  • Currently taking hormone replacement medication.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02135172
Other Study ID Numbers  ICMJE 0376
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Leicester
Study Sponsor  ICMJE University of Leicester
Collaborators  ICMJE
  • National Institute for Health Research, United Kingdom
  • National Health Service, United Kingdom
Investigators  ICMJE
Principal Investigator: Melanie J Davies, MD University of Leicester
PRS Account University of Leicester
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP