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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02135172
Other study ID # 0376
Secondary ID
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


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
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