Breaks in Sedentary Time and Glucose Regulation in Women

Impaired Glucose Tolerance Clinical Trial

— ACUTE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02135172
• Other study ID #: 0376
• Status: Completed
• Phase: N/A
• First received: January 2, 2014
• Last updated: December 9, 2014
• Start date: October 2013
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• Source: University of Leicester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 74 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Glucose Intolerance
• Impaired Glucose Tolerance

Intervention

Behavioral:
• Sitting

• Standing

• Walking

Locations

Country	Name	City	State
United Kingdom	Leicester Diabetes Centre, Leicester General Hospital	Leicester	Leicestershire

Sponsors (3)

Lead Sponsor	Collaborator
University of Leicester	National Health Service, United Kingdom, National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	0 weeks and 2 weeks	No
Secondary	Insulin area under the curve		0 weeks and 2 weeks	No
Secondary	Triacylglycerol area under the curve		0 weeks and 2 weeks	No
Secondary	Lipoprotein lipase activity		0 weeks and 2 weeks	No

External Links

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