Breaks in Sedentary Time and Glucose Regulation in Women
ACUTE
Does Breaking Sedentary Time Improve Glucose Regulation in Women With Impaired Glucose Tolerance? A Balanced Incomplete Block Design Study
1 other identifier
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 2, 2014
CompletedFirst Posted
Study publicly available on registry
May 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedDecember 10, 2014
December 1, 2014
1.1 years
January 2, 2014
December 9, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Glucose area under the curve
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.
0 weeks and 2 weeks
Secondary Outcomes (3)
Insulin area under the curve
0 weeks and 2 weeks
Triacylglycerol area under the curve
0 weeks and 2 weeks
Lipoprotein lipase activity
0 weeks and 2 weeks
Study Arms (3)
Sitting
EXPERIMENTALDuring 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.
Standing
EXPERIMENTALThis 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.
Walking
EXPERIMENTALThis 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.
Interventions
Eligibility Criteria
You may qualify if:
- Sedentary
- Overweight or obese (BMI\>25kg/m2)
- Post menopausal
- Previous diagnosis of impaired glucose tolerance
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Leicester Diabetes Centre, Leicester General Hospital
Leicester, Leicestershire, LE5 4PW, United Kingdom
Related Publications (1)
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.
PMID: 26628415DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Melanie J Davies, MD
University of Leicester
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2014
First Posted
May 9, 2014
Study Start
October 1, 2013
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
December 10, 2014
Record last verified: 2014-12