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CompletedNCT02135172ACUTEUpdated Dec 10, 2014

Breaks in Sedentary Time and Glucose Regulation in Women

An interventional study of Sitting and Standing in Impaired Glucose Tolerance, sponsored by University of Leicester. Completed at 1 site in United Kingdom. Open to female participants aged 50 Years to 74 Years. Per ClinicalTrials.gov, last updated 2014-12-10.

Sponsored by University of Leicester · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
50 Years to 74 Years
Sex
Female
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Study 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.

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Conditions studied

  • Impaired Glucose Tolerance

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03

In context

Glucose Intolerance

778 studies on the registry are indexed under Glucose Intolerance; 129 are open to participants now.

This study's enrollment of 22 is below the median of 60 across 645 interventional studies indexed under Glucose Intolerance.

Browse Glucose Intolerance studies →

Lead sponsor

University of Leicester is the lead sponsor of 166 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 74 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • 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.

    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.

    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.

    Behavioral: Walking

Interventions

  • BehavioralSitting
  • BehavioralStanding
  • BehavioralWalking
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What researchers measure

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.

    Time frame: 0 weeks and 2 weeks

Secondary outcomes

  1. Insulin area under the curve

    Time frame: 0 weeks and 2 weeks

  2. Triacylglycerol area under the curve

    Time frame: 0 weeks and 2 weeks

  3. Lipoprotein lipase activity

    Time frame: 0 weeks and 2 weeks

07

Study locations

1 site
  • Leicester Diabetes Centre, Leicester General Hospital
    Leicester, Leicestershire LE5 4PW, United Kingdom
08

References and documents

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. PubMed 26628415 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02135172
Lead sponsor
University of Leicester
Collaborators
National Institute for Health Research, United Kingdom, National Health Service, United Kingdom
Responsible party
Sponsor
First posted
May 9, 2014
Start date
Oct 2013
Primary completion
Nov 2014
Completion
Nov 2014
Last update
Dec 10, 2014

Study contacts

Melanie J Davies, MD
principal investigator · University of Leicester

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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