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OpenTrials
Completed

NCT Number: NCT02135172

Breaks in Sedentary Time and Glucose Regulation in Women

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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Key information

Age range

50 year–74 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Leicester Diabetes Centre, Leicester General Hospital

Leicester, Leicestershire, LE5 4PW, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sitting

Behavioral

Standing

Behavioral

Walking

Behavioral

Primary outcomes

  1. 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.

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

Sponsors and collaborators

Lead sponsor

University of Leicester

Other

Collaborators

  • National Health Service, United Kingdom
  • National Institute for Health Research, United Kingdom

Registry information

Official study title

Does Breaking Sedentary Time Improve Glucose Regulation in Women With Impaired Glucose Tolerance? A Balanced Incomplete Block Design Study

Acronym: ACUTE

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 9, 2014
Registry last updated
Dec 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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