Breaks in Sedentary Time and Glucose Regulation in Women

NCT ID: NCT02135172

Last Updated: 2014-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-11-30

Brief Summary

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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

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Conditions

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Impaired Glucose Tolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Sitting

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

Standing

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

Walking

Intervention Type BEHAVIORAL

Interventions

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Sitting

Intervention Type BEHAVIORAL

Standing

Intervention Type BEHAVIORAL

Walking

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

74 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

National Health Service, United Kingdom

OTHER_GOV

Sponsor Role collaborator

University of Leicester

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Melanie J Davies, MD

Role: PRINCIPAL_INVESTIGATOR

University of Leicester

Locations

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Leicester Diabetes Centre, Leicester General Hospital

Leicester, Leicestershire, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 26628415 (View on PubMed)

Related Links

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http://www.ll.dlpa.bru.nihr.ac.uk

Click here for more information about this study

Other Identifiers

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0376

Identifier Type: -

Identifier Source: org_study_id