Clinical trial NCT02135172: Breaks in Sedentary Time and Glucose Regulation in Women
Official title: Does Breaking Sedentary Time Improve Glucose Regulation in Women With Impaired Glucose Tolerance? A Balanced Incomplete Block Design Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impaired Glucose Tolerance
Lead sponsor: University of Leicester
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: National Health Service, United Kingdom
First posted: 2014-05-09
Enrollment: 22
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Glucose area under the curve
timeFrame: 0 weeks and 2 weeks
Secondary outcomes:
measure: Insulin area under the curve
timeFrame: 0 weeks and 2 weeks
measure: Triacylglycerol area under the curve
timeFrame: 0 weeks and 2 weeks
measure: Lipoprotein lipase activity
timeFrame: 0 weeks and 2 weeks
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Leicester Diabetes Centre, Leicester General Hospital
state: Leicestershire
Study officials:
affiliation: University of Leicester
name: Melanie J Davies, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.