Type 2 Diabetes MellitusUP FOR 5NCT03482596
The Effects of Reducing Prolonged Sitting Bouts in Individuals at High Risk of or With Type 2 Diabetes
A study testing Reducing/breaking prolonged sitting in people with Type 2 Diabetes Mellitus, run by University of Leicester at 1 site in United Kingdom.
Trial 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 developing cardiovascular disease, kidney disease, depression, neuropathy and dementia, along with being a leading cause of… Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Reducing/breaking prolonged sitting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Feb 2018to 4 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
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- 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
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leicester Diabetes Centre
Leicester, Leicestershire, LE5 4PW
About this study
Official title: The Effects of Reducing Prolonged Sitting Bouts With Regular Light Upright Movement Breaks on Glucose Regulation in Individuals at High Risk of or With Type 2 Diabetes
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 developing cardiovascular disease, kidney disease, depression, neuropathy and dementia, along with being a leading cause of amputation and adult blindness.
Sedentary behaviour, defined as any waking moment spend sitting or reclining with energy expenditure equal to or less than 1.5 METs, has emerged as a risk factor in the development of type 2 diabetes. Recent evidence has shown that breaking up prolonged sitting with regular short bouts of activity or standing lower postprandial glucose and insulin. However, the effectiveness of breaking prolonged sitting on glucose metabolism over a longer period of time is unknown. Therefore, the aim of this study is to investigate whether the reduction in postprandial plasma glucose in response to breaking prolonged sitting time is maintained following an intervention to reduce and break up prolonged sitting over a four to five week period.
The study will be a single group intervention with pre and post randomised measurement conditions (prolonged sitting and light upright breaks) at both time points. A sample of 43 people (34 to complete), aged 50-75, identified as at risk of or with (drug naive) type 2 diabetes will be sought. The intervention will last approximately 5 weeks. Experimental conditions will be conducted before and after the intervention to assess whether reducing and breaking up prolonged sitting in free living effects glucose metabolism.
Read the 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 prior to the intervention and one at the end of the intervention used as measurement periods. Screening will require one laboratory visit, with the study commencing one week following baseline. The intervention will last a minimum of four weeks, while the measurement conditions will each involve two laboratory days separated by a minimum of five days. The duration from screening through to study end will be an estimated 9 weeks. This trial will evaluate the effectiveness of regular light upright movement breaks at reducing glucose iAUC by examining if acute adaptations to sitting time are maintained or improved following the behavioural intervention.
Study Setting
The study will be co-ordinated within the Leicester Biomedical Research Centre (Leicester Diabetes Centre) at the Leicester General Hospital. Clinical measurement sessions will be carried out by the appointed research team. Participants will be asked to visit the study centre on seven occasions.
Measurement conditions
Measurement condition A will consist of seven and a half hours of prolonged sitting, where participants will be restricted from walking or standing for the duration. Lavatory breaks will be carried out using a wheelchair to transport the participant to minimise time spent upright. The condition will be conducted in the laboratory at the Leicester Diabetes Centre. Participants will have access to a computer with internet services, books and magazines for the duration of the measurement day.
Upon arrival, the participant will have a cannula inserted into an accessible vein by a trained member of the study team, which will be used to collect blood samples throughout the measurement day. Blood pressure will be taken prior to each blood sample, while visual analogue scales for hunger, energy, fullness, satiety, desire to eat and fatigue will be completed following each blood sample. The first blood sample will be taken at the start of the 'steady state' following anthropometric measurements. The next sample will be taken one hour after the first sample. Following this, participants will be given a standardized meal consumed over a maximum of 15 minutes. Blood samples will be then be taken at 30, 60, 120 and 180 minutes after commencing eating. Another standardized meal and the same schedule of blood sampling will take place following the blood sample taken 180 minutes postprandial to the first meal. Meals will be based on body weight, with eight kcals per kg of body weight, made up of 52% carbohydrate, 35% fats and 13% protein.
Measurement condition B will follow the same procedures as condition A in terms of standardised meals, blood sampling, blood pressure, visual analogue scales and meal consumption. Similarly, participants will be allowed access to a lavatory in the same way as condition A, as well as have access to a computer, books, magazines and other typical sedentary pursuits. The only difference in this measurement condition to condition A, is that participants will regularly break their sitting time, for five minutes every 30 minutes with upright light movement after sitting quietly for one hour upon arrival and following cannulation (steady state). This will involve the participant walking and moving around slowly and freely in the testing room and surrounding laboratory. This is to maximise the ecological validity of the study, particularly in comparison to studies using a treadmill for light walking breaks. Five minute breaks every 30 minutes was chosen as this has previously shown positive effects on both glucose metabolism and insulin in postmenopausal women (19). Light breaks will accumulate 60 minutes of light upright movement across the measurement day.
Intervention
The participants will be encouraged to reduce prolonged sitting by at least 60 minutes per day by introducing light upright movement breaks spread throughout their day. The frequency and duration of these breaks will be tailored to each participant to suit their individual circumstances. A 60 minute reduction is judged to be clinically meaningful. For example, a modelling study found that replacing 60 minutes of sedentary time with light movement was associated with around 20% better insulin sensitivity in those with dysglycemia.
The intervention will involve one participant face-to-face session, lasting approximately two hours. It will also involve personalised feedback which will review progress and goals based on the baseline data. The visit will involve personalised education and goal setting, based on objective measures of sitting time taken at baseline. These data will be explained to the participant, which will then form the basis of a plan to reduce prolonged bouts of sitting with light movement. This session will also explain what is meant by light movement, as well as identifying a number of different ways to break prolonged bouts effectively. Participants will be encouraged to self-monitor their sitting time, with specific examples of how his can be achieved depending on the needs of the participant. They will be given an accelerometer to be worn for the duration of the four week intervention.
The participant will receive feedback from a member of the study team on at least a weekly basis (more frequently feedback expected in the early weeks) in regards to current sedentary behavior and movement time. Data received from the accelerometer or self-monitoring device will be used to discuss the positives and negatives of the previous days or week's behaviour. These will be talked through and adjustments made to the goals if needed. The feedback sessions will take place primarily over the telephone, however if the participant would like to visit the Leicester Diabetes Centre for these sessions that will be made available to them. All feedback is personalised meaning it will be different for each participant in terms of the data fed back as well as the timings of each feedback session
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Reducing/breaking prolonged sitting
- Keywords
- Sedentary Behaviour, Prevention
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reducing/breaking prolonged sittingBehavioural
The participants will be encouraged to reduce prolonged sitting by at least 60 minutes per day by introducing light upright movement breaks spread throughout their day. The frequency and duration of these breaks will be tailored to each participant to suit their individual circumstances.
The intervention will involve education regarding the health implications of prolonged sitting, personalised goal setting, behavioural feedback and self-monitoring of behaviour.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | All participants will follow the personalised multifaceted intervention to reducing/breaking prolonged sitting. Receives: Behavioral: Reducing/breaking prolonged sitting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose incremental Area Under the Curve (iAUC)
Glucose iAUC will be used to assess whether, following the intervention, the expected improvement in glucose metabolism is maintained or improved in the post-measurement conditions compared to the pre-measurement conditions.
Measured: Assessed via 10 blood samples.Two of which will be taken while fasting and the remainder taken at 30, 60, 120 and 180 minutes following both breakfast and lunch meals. This will be assessed for all of the 7.5 hour experimental treatment conditions
Secondary outcomes (33)
Insulin incremental Area Under the Curve (iAUC)
iAUC will be used to assess whether, following the intervention, the expected reduction in insulin is maintained or improved in the post-measurement conditions compared to the pre-measurement conditions.
Measured: Assessed via 10 blood samples.Two of which will be taken while fasting and the remainder taken at 30, 60, 120 and 180 minutes following both breakfast and lunch meals. This will be assessed for all of the 7.5 hour experimental treatment conditions
Triglycerides incremental Area Under the Curve (iAUC)
iAUC will be used to assess whether, following the intervention, the expected reduction in triglycerides is maintained or improved in the post-measurement conditions compared to the pre-measurement conditions.
Measured: Assessed via 10 blood samples.Two of which will be taken while fasting and the remainder taken at 30, 60, 120 and 180 minutes following both breakfast and lunch meals. This will be assessed for all of the 7.5 hour experimental treatment conditions
Blood pressure incremental Area Under the Curve (iAUC)
Measured: Assessed prior to all 10 blood samples. This will be assessed for all of the 7.5 hour experimental treatment conditions
Acylated ghrelin
Appetite hormone
Measured: Assessed via 5 blood samples, One of which is taken fasted and the remainder taken at 30, 60, 120 and 180 minutes following breakfast during condition A
Total PYY
Appetite hormone
Measured: Assessed via 5 blood samples, One of which is taken fasted and the remainder taken at 30, 60, 120 and 180 minutes following breakfast during condition A
Subjective appetite - Hunger
Measure via a visual analog scale. Scale ranges from 0 to 100. The higher the number the more hungry the person feels.
Measured: Assessed after each blood sample during every experimental condition. Through study completion, an average of 9 weeks.
Subjective appetite - Fullness
Measure via a visual analog scale. Scale ranges from 0 to 100. The higher the score, the more full a person feels.
Measured: Assessed after each blood sample during every experimental condition. Through study completion, an average of 9 weeks.
Subjective appetite - Satiety
Measure via a visual analog scale. Scale ranges from 0 to 100. The higher the score, the more satisfied a person feels.
Measured: Assessed after each blood sample during every experimental condition. Through study completion, an average of 9 weeks.
Subjective appetite - Quantity
Measure via a visual analog scale. Scale ranges from 0 to 100. The higher the score, the more someone believes they can eat.
Measured: Assessed after each blood sample during every experimental condition. Through study completion, an average of 9 weeks.
Fatigue (acute)
Measure via a visual analog scale, one for energy and one for fatigue. Scale ranges from 0 to 100. The higher the number, the more fatigued someone feels.
Measured: Assessed after each blood sample during every experimental condition. Through study completion, an average of 9 weeks.
Energy (acute)
Measure via a visual analog scale, one for energy and one for fatigue. Scale ranges from 0 to 100. The higher the number, the more energetic someone feels
Measured: Assessed after each blood sample during every experimental condition. Through study completion, an average of 9 weeks.
Fasting glucose
Measured: Before and after the intervention. Through study completion, an average of 9 weeks.
Fasting insulin
Measured: Before and after the intervention. Through study completion, an average of 9 weeks.
Fasting triglycerides
Measured: Before and after the intervention. Through study completion, an average of 9 weeks.
Fasting IL-6
Measured: Before and after the intervention. Through study completion, an average of 9 weeks.
Cholesterol
Measured: Before and after the intervention. Through study completion, an average of 9 weeks.
HDL Cholesterol
Measured: Before and after the intervention. Through study completion, an average of 9 weeks.
LDL Cholesterol
Measured: Before and after the intervention. Through study completion, an average of 9 weeks.
Fasting creatinine
Serum creatinine is an important indicator of renal health because it is an easily measured by-product of muscle metabolism that is excreted unchanged by the kidneys.
Measured: Before and after the intervention. Through study completion, an average of 9 weeks.
Mood
Profile of Mood States
Measured: Baseline and last week of the intervention. Through study completion, an average of 9 weeks.
Depressive symptoms
Center for Epidemiologic Studies Depression Scale
Measured: Baseline and last week of the intervention. Through study completion, an average of 9 weeks.
Chronic fatigue
Chalder Fatigue Scale
Measured: Baseline and last week of the intervention. Through study completion, an average of 9 weeks.
Average blood glucose
Measure via continuous glucose monitors
Measured: Week following baseline and during the last week of the intervention. Through study completion, an average of 9 weeks.
Time spent in hypoglycemia
Measure via continuous glucose monitors
Measured: Week following baseline and during the last week of the intervention. Through study completion, an average of 9 weeks.
Time spent in hyperglycemia
Measure via continuous glucose monitors
Measured: Week following baseline and during the last week of the intervention. Through study completion, an average of 9 weeks.
Physical function
Measure via a battery of tests: The MINIBESTest, 30 second chair sit stand test, 20 meter walk test and grip strength.
Measured: Baseline and at the end of the intervention. Through study completion, an average of 9 weeks.
Adherence to the intervention
Measure via accelerometer
Measured: Data during the intervention period will be compared to baseline. Through study completion, an average of 9 weeks.
Physical behaviours
sleep, sitting, standing, stepping
Measured: Data during the intervention period will be compared to baseline. Through study completion, an average of 9 weeks.
Sedentary time
Accelerometer sedentary time
Measured: Data during the intervention period will be compared to baseline. Through study completion, an average of 9 weeks.
Light intensity physical activity
Accelerometer derived Light intensity physical activity
Measured: Data during the intervention period will be compared to baseline. Through study completion, an average of 9 weeks.
Moderate to vigorous intensity physical activity (MVPA)
Accelerometer derived moderate intensity activity and vigorous intensity activity. These will be combined to created one variable, MVPA
Measured: Data during the intervention period will be compared to baseline. Through study completion, an average of 9 weeks.
Sleep
Sleep will be derived from the accelerometer wear diaries.
Measured: Data during the intervention period will be compared to baseline. Through study completion, an average of 9 weeks.
Intervention perception
Interviews
Measured: Conducted at the end of the intervention. Through study completion, an average of 9 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start21 Feb 2018
- Primary completion4 Jul 2019
- Study completion4 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals, Leicester, Loughborough University, Baker Heart and Diabetes Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482596
- Sponsor's protocol ID
- 0641
- Acronym
- UP FOR 5
- Status last verified
- Jan 2020
- First submitted
- 5 Mar 2018
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Reducing Prolonged Sitting Bouts With Regular Light Upright Movement Breaks on Glucose Regulation in Individuals at High Risk of or With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03482596
- Acronym / sponsor ID
- UP FOR 5 / 0641
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Sedentary Behaviour, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- University Hospitals, Leicester, Loughborough University, Baker Heart and Diabetes Institute
- Study start
- 21 Feb 2018 (actual)
- Primary completion
- 4 Jul 2019 (actual)
- Study completion
- 4 Jul 2019 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 developing cardiovascular disease, kidney disease, depression, neuropathy and dementia, along with being a leading cause of amputation and adult blindness.
Sedentary behaviour, defined as any waking moment spend sitting or reclining with energy expenditure equal to or less than 1.5 METs, has emerged as a risk factor in the development of type 2 diabetes. Recent evidence has shown that breaking up prolonged sitting with regular short bouts of activity or standing lower postprandial glucose and insulin. However, the effectiveness of breaking prolonged sitting on glucose metabolism over a longer period of time is unknown. Therefore, the aim of this study is to investigate whether the reduction in postprandial plasma glucose in response to breaking prolonged sitting time is maintained following an intervention to reduce and break up prolonged sitting over a four to five week period.
The study will be a single group intervention with pre and post randomised measurement conditions (prolonged sitting and light upright breaks) at both time points. A sample of 43 people (34 to complete), aged 50-75, identified as at risk of or with (drug naive) type 2 diabetes will be sought. The intervention will last approximately 5 weeks. Experimental conditions will be conducted before and after the intervention to assess whether reducing and breaking up prolonged sitting in free living effects glucose metabolism.
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 prior to the intervention and one at the end of the intervention used as measurement periods. Screening will require one laboratory visit, with the study commencing one week following baseline. The intervention will last a minimum of four weeks, while the measurement conditions will each involve two laboratory days separated by a minimum of five days. The duration from screening through to study end will be an estimated 9 weeks. This trial will evaluate the effectiveness of regular light upright movement breaks at reducing glucose iAUC by examining if acute adaptations to sitting time are maintained or improved following the behavioural intervention.
Study Setting
The study will be co-ordinated within the Leicester Biomedical Research Centre (Leicester Diabetes Centre) at the Leicester General Hospital. Clinical measurement sessions will be carried out by the appointed research team. Participants will be asked to visit the study centre on seven occasions.
Measurement conditions
Measurement condition A will consist of seven and a half hours of prolonged sitting, where participants will be restricted from walking or standing for the duration. Lavatory breaks will be carried out using a wheelchair to transport the participant to minimise time spent upright. The condition will be conducted in the laboratory at the Leicester Diabetes Centre. Participants will have access to a computer with internet services, books and magazines for the duration of the measurement day.
Upon arrival, the participant will have a cannula inserted into an accessible vein by a trained member of the study team, which will be used to collect blood samples throughout the measurement day. Blood pressure will be taken prior to each blood sample, while visual analogue scales for hunger, energy, fullness, satiety, desire to eat and fatigue will be completed following each blood sample. The first blood sample will be taken at the start of the 'steady state' following anthropometric measurements. The next sample will be taken one hour after the first sample. Following this, participants will be given a standardized meal consumed over a maximum of 15 minutes. Blood samples will be then be taken at 30, 60, 120 and 180 minutes after commencing eating. Another standardized meal and the same schedule of blood sampling will take place following the blood sample taken 180 minutes postprandial to the first meal. Meals will be based on body weight, with eight kcals per kg of body weight, made up of 52% carbohydrate, 35% fats and 13% protein.
Measurement condition B will follow the same procedures as condition A in terms of standardised meals, blood sampling, blood pressure, visual analogue scales and meal consumption. Similarly, participants will be allowed access to a lavatory in the same way as condition A, as well as have access to a computer, books, magazines and other typical sedentary pursuits. The only difference in this measurement condition to condition A, is that participants will regularly break their sitting time, for five minutes every 30 minutes with upright light movement after sitting quietly for one hour upon arrival and following cannulation (steady state). This will involve the participant walking and moving around slowly and freely in the testing room and surrounding laboratory. This is to maximise the ecological validity of the study, particularly in comparison to studies using a treadmill for light walking breaks. Five minute breaks every 30 minutes was chosen as this has previously shown positive effects on both glucose metabolism and insulin in postmenopausal women (19). Light breaks will accumulate 60 minutes of light upright movement across the measurement day.
Intervention
The participants will be encouraged to reduce prolonged sitting by at least 60 minutes per day by introducing light upright movement breaks spread throughout their day. The frequency and duration of these breaks will be tailored to each participant to suit their individual circumstances. A 60 minute reduction is judged to be clinically meaningful. For example, a modelling study found that replacing 60 minutes of sedentary time with light movement was associated with around 20% better insulin sensitivity in those with dysglycemia.
The intervention will involve one participant face-to-face session, lasting approximately two hours. It will also involve personalised feedback which will review progress and goals based on the baseline data. The visit will involve personalised education and goal setting, based on objective measures of sitting time taken at baseline. These data will be explained to the participant, which will then form the basis of a plan to reduce prolonged bouts of sitting with light movement. This session will also explain what is meant by light movement, as well as identifying a number of different ways to break prolonged bouts effectively. Participants will be encouraged to self-monitor their sitting time, with specific examples of how his can be achieved depending on the needs of the participant. They will be given an accelerometer to be worn for the duration of the four week intervention.
The participant will receive feedback from a member of the study team on at least a weekly basis (more frequently feedback expected in the early weeks) in regards to current sedentary behavior and movement time. Data received from the accelerometer or self-monitoring device will be used to discuss the positives and negatives of the previous days or week's behaviour. These will be talked through and adjustments made to the goals if needed. The feedback sessions will take place primarily over the telephone, however if the participant would like to visit the Leicester Diabetes Centre for these sessions that will be made available to them. All feedback is personalised meaning it will be different for each participant in terms of the data fed back as well as the timings of each feedback session
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Reducing/breaking prolonged sittingAll participants will follow the personalised multifaceted intervention to reducing/breaking prolonged sitting. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and Postmenopausal Females.
- ≥ 40 to ≤ 75 years of age.
- And either:
- Large proportions of their day spent sitting (self-reported).
- Participant is willing and able to give informed consent to take part in the study.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reducing/breaking prolonged sittingThe participants will be encouraged to reduce prolonged sitting by at least 60 minutes per day by introducing light upright movement breaks spread throughout their day. The frequency and duration of these breaks will be tailored to each participant to suit their individual circumstances. The intervention will involve education regarding the health implications of prolonged sitting, personalised goal setting, behavioural feedback and self-monitoring of behaviour. | Behavioural | Intervention |
Primary outcome
Glucose incremental Area Under the Curve (iAUC)
Time frame: Assessed via 10 blood samples.Two of which will be taken while fasting and the remainder taken at 30, 60, 120 and 180 minutes following both breakfast and lunch meals. This will be assessed for all of the 7.5 hour experimental treatment conditions
Glucose iAUC will be used to assess whether, following the intervention, the expected improvement in glucose metabolism is maintained or improved in the post-measurement conditions compared to the pre-measurement conditions.
33 secondary outcomes
Insulin incremental Area Under the Curve (iAUC)
Time frame: Assessed via 10 blood samples.Two of which will be taken while fasting and the remainder taken at 30, 60, 120 and 180 minutes following both breakfast and lunch meals. This will be assessed for all of the 7.5 hour experimental treatment conditions
Triglycerides incremental Area Under the Curve (iAUC)
Time frame: Assessed via 10 blood samples.Two of which will be taken while fasting and the remainder taken at 30, 60, 120 and 180 minutes following both breakfast and lunch meals. This will be assessed for all of the 7.5 hour experimental treatment conditions
Blood pressure incremental Area Under the Curve (iAUC)
Time frame: Assessed prior to all 10 blood samples. This will be assessed for all of the 7.5 hour experimental treatment conditions
Acylated ghrelin
Time frame: Assessed via 5 blood samples, One of which is taken fasted and the remainder taken at 30, 60, 120 and 180 minutes following breakfast during condition A
Total PYY
Time frame: Assessed via 5 blood samples, One of which is taken fasted and the remainder taken at 30, 60, 120 and 180 minutes following breakfast during condition A
Subjective appetite - Hunger
Time frame: Assessed after each blood sample during every experimental condition. Through study completion, an average of 9 weeks.
Subjective appetite - Fullness
Time frame: Assessed after each blood sample during every experimental condition. Through study completion, an average of 9 weeks.
Subjective appetite - Satiety
Time frame: Assessed after each blood sample during every experimental condition. Through study completion, an average of 9 weeks.
Subjective appetite - Quantity
Time frame: Assessed after each blood sample during every experimental condition. Through study completion, an average of 9 weeks.
Fatigue (acute)
Time frame: Assessed after each blood sample during every experimental condition. Through study completion, an average of 9 weeks.
Energy (acute)
Time frame: Assessed after each blood sample during every experimental condition. Through study completion, an average of 9 weeks.
Fasting glucose
Time frame: Before and after the intervention. Through study completion, an average of 9 weeks.
Fasting insulin
Time frame: Before and after the intervention. Through study completion, an average of 9 weeks.
Fasting triglycerides
Time frame: Before and after the intervention. Through study completion, an average of 9 weeks.
Fasting IL-6
Time frame: Before and after the intervention. Through study completion, an average of 9 weeks.
Cholesterol
Time frame: Before and after the intervention. Through study completion, an average of 9 weeks.
HDL Cholesterol
Time frame: Before and after the intervention. Through study completion, an average of 9 weeks.
LDL Cholesterol
Time frame: Before and after the intervention. Through study completion, an average of 9 weeks.
Fasting creatinine
Time frame: Before and after the intervention. Through study completion, an average of 9 weeks.
Mood
Time frame: Baseline and last week of the intervention. Through study completion, an average of 9 weeks.
Depressive symptoms
Time frame: Baseline and last week of the intervention. Through study completion, an average of 9 weeks.
Chronic fatigue
Time frame: Baseline and last week of the intervention. Through study completion, an average of 9 weeks.
Average blood glucose
Time frame: Week following baseline and during the last week of the intervention. Through study completion, an average of 9 weeks.
Time spent in hypoglycemia
Time frame: Week following baseline and during the last week of the intervention. Through study completion, an average of 9 weeks.
Time spent in hyperglycemia
Time frame: Week following baseline and during the last week of the intervention. Through study completion, an average of 9 weeks.
Physical function
Time frame: Baseline and at the end of the intervention. Through study completion, an average of 9 weeks.
Adherence to the intervention
Time frame: Data during the intervention period will be compared to baseline. Through study completion, an average of 9 weeks.
Physical behaviours
Time frame: Data during the intervention period will be compared to baseline. Through study completion, an average of 9 weeks.
Sedentary time
Time frame: Data during the intervention period will be compared to baseline. Through study completion, an average of 9 weeks.
Light intensity physical activity
Time frame: Data during the intervention period will be compared to baseline. Through study completion, an average of 9 weeks.
Moderate to vigorous intensity physical activity (MVPA)
Time frame: Data during the intervention period will be compared to baseline. Through study completion, an average of 9 weeks.
Sleep
Time frame: Data during the intervention period will be compared to baseline. Through study completion, an average of 9 weeks.
Intervention perception
Time frame: Conducted at the end of the intervention. Through study completion, an average of 9 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reducing/breaking prolonged sitting in people with Type 2 Diabetes Mellitus, run by University of Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose incremental Area Under the Curve (iAUC) (time frame: Assessed via 10 blood samples.Two of which will be taken while fasting and the remainder taken at 30, 60, 120 and 180 minutes following both breakfast and lunch meals. This will be assessed for all of the 7.5 hour experimental treatment conditions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2020.