Status:
COMPLETED
The Effects of Reducing Prolonged Sitting Bouts in Individuals at High Risk of or With Type 2 Diabetes
Lead Sponsor:
University of Leicester
Collaborating Sponsors:
University Hospitals, Leicester
Loughborough University
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief Summary
Over 3 million in the United Kingdom are now diagnosed with type 2 diabetes, with current estimates suggesting this will rise to over 5 million by 2025. Type 2 diabetes increases the risk of developin...
Detailed Description
Study Design This study consists of an intervention lasting approximately 5 weeks (depending on follow-up measurement timings), with a before and after 'two-arm' randomised crossover design, one prio...
Eligibility Criteria
Inclusion
- Male and Postmenopausal Females.
- ≥ 40 to ≤ 75 years of age.
- And either:
- Overweight (White: BMI \> 25 - \<30, South Asian, Black or Chinese: \> 23 \<27.5) with HbA1c between 6.0 and 7.5%, within the previous 36 months).
- Obese (White: BMI ≥ 30, South Asian, Black or Chinese: ≥ 27.5).
- Large proportions of their day spent sitting (self-reported).
- Participant is willing and able to give informed consent to take part in the study.
- Not planning on altering their diet during the study.
- Able to walk without the use of an assistive device or requiring assistance form another person
Exclusion
- The participant may not enter the study if ANY of the following apply:
- Reporting taking part in regular (at least once a week) sport of strenuous exercise.
- HbA1c \> 7.5%.
- Overweight with HbA1c \< 6.0%.
- Taking any glucose lowering therapies.
- Type 1 diabetes.
- Recent cardiovascular event (within the last 12 months).
- Female premenopausal.
- Current smoker.
- Terminal illness.
- Steroid use.
- Comorbidity that the research team consider to be a contraindication to involvement in the study
- Unable to communicate in English.
- Unable to provide written informed consent.
- In the circumstance that an individual is not sure whether they meet the inclusion/ exclusion criteria, they will be reviewed by a named medic on the delegation of authority log for a clinical decision to be made during the baseline visit.
Key Trial Info
Start Date :
February 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 4 2019
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT03482596
Start Date
February 21 2018
End Date
July 4 2019
Last Update
January 30 2020
Active Locations (1)
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1
Leicester Diabetes Centre
Leicester, Leicestershire, United Kingdom, LE5 4PW