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Trial record 51 of 7576 for:    Area Under Curve

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

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ClinicalTrials.gov Identifier: NCT02135172
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : December 10, 2014
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
National Health Service, United Kingdom
Information provided by (Responsible Party):
University of Leicester

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.

Condition or disease Intervention/treatment Phase
Impaired Glucose Tolerance Behavioral: Sitting Behavioral: Standing Behavioral: Walking Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Does Breaking Sedentary Time Improve Glucose Regulation in Women With Impaired Glucose Tolerance? A Balanced Incomplete Block Design Study
Study Start Date : October 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   50 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135172


Locations
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United Kingdom
Leicester Diabetes Centre, Leicester General Hospital
Leicester, Leicestershire, United Kingdom, LE5 4PW
Sponsors and Collaborators
University of Leicester
National Institute for Health Research, United Kingdom
National Health Service, United Kingdom
Investigators
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Principal Investigator: Melanie J Davies, MD University of Leicester

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Leicester
ClinicalTrials.gov Identifier: NCT02135172     History of Changes
Other Study ID Numbers: 0376
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: December 10, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Glucose Intolerance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases