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Breaks in Sedentary Time and Glucose Regulation in Women (ACUTE)

Primary Purpose

Impaired Glucose Tolerance

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Sitting
Standing
Walking
Sponsored by
University of Leicester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Impaired Glucose Tolerance

Eligibility Criteria

50 Years - 74 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Leicester Diabetes Centre, Leicester General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Sitting

Standing

Walking

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Insulin area under the curve
Triacylglycerol area under the curve
Lipoprotein lipase activity

Full Information

First Posted
January 2, 2014
Last Updated
December 9, 2014
Sponsor
University of Leicester
Collaborators
National Institute for Health Research, United Kingdom, National Health Service, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT02135172
Brief Title
Breaks in Sedentary Time and Glucose Regulation in Women
Acronym
ACUTE
Official Title
Does Breaking Sedentary Time Improve Glucose Regulation in Women With Impaired Glucose Tolerance? A Balanced Incomplete Block Design Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Leicester
Collaborators
National Institute for Health Research, United Kingdom, National Health Service, United Kingdom

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Glucose Tolerance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sitting
Arm Type
Experimental
Arm Description
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.
Arm Title
Standing
Arm Type
Experimental
Arm Description
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.
Arm Title
Walking
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Sitting
Intervention Type
Behavioral
Intervention Name(s)
Standing
Intervention Type
Behavioral
Intervention Name(s)
Walking
Primary Outcome Measure Information:
Title
Glucose area under the curve
Description
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 Outcome Measure Information:
Title
Insulin area under the curve
Time Frame
0 weeks and 2 weeks
Title
Triacylglycerol area under the curve
Time Frame
0 weeks and 2 weeks
Title
Lipoprotein lipase activity
Time Frame
0 weeks and 2 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melanie J Davies, MD
Organizational Affiliation
University of Leicester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leicester Diabetes Centre, Leicester General Hospital
City
Leicester
State/Province
Leicestershire
ZIP/Postal Code
LE5 4PW
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26628415
Citation
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.
Results Reference
derived
Links:
URL
http://www.ll.dlpa.bru.nihr.ac.uk
Description
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Breaks in Sedentary Time and Glucose Regulation in Women

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