DiabetesFIT2SITNCT02493309
FIT 2 SIT - Are Metabolic Responses to Sitting/Light Breaks Mediated by Fitness?
A study testing Prolonged sitting and Light activity breaks in people with Diabetes, run by University of Leicester at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine whether an individuals cardio-respiratory fitness level can protect them from the negative metabolic impacts of prolonged sitting time. Overall, it is hypothesised that in individuals with high fitness, the unfavourable effect of prolonged sitting (build up of sugar, fat and… Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Prolonged sitting and Light activity breaks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2014to Oct 2015
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study
- Body Mass Index: 20 - 30 kg/m2
- Male and Female
- Aged: ≥ 25 to ≤ 55 years of age.
- Occupation: Work full-time in a predominantly sedentary occupation.
Who cannot join
- Due to the nature of the trial, our exclusion criteria are as follows:
- The participant may not enter the study if ANY of the following apply:
- Aged <25 or >55 years of age.
- 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
Show all 12Show fewer
- Steroid use
- Known Type 2 Diabetes
- Pre-existing Cardio-vascular Disease (disease of the heart or blood vessels at present or in the past) For example: Heart attack, Stroke or Angina.
- Pregnancy
- Smoker
- Terminal illness
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leicester Diabetes Centre, Leicester General Hospital
Leicester, Leicestershire, LE5 4PW
About this study
Official title: The Impact of Cardio-respiratory Fitness on an Individual's Metabolic Response to Sitting and Light Activity Breaks
The purpose of this study is to determine whether an individuals cardio-respiratory fitness level can protect them from the negative metabolic impacts of prolonged sitting time.
Overall, it is hypothesised that in individuals with high fitness, the unfavourable effect of prolonged sitting (build up of sugar, fat and insulin in the blood following a meal) will not be as substantial, nor will light activity breaks be as advantageous, compared to individuals with lower fitness as they have a smaller scope for metabolic improvement.
Read the detailed description
The FIT 2 SIT study requires three separate study visits in total.
At visit one, we will check the participants blood pressure, height, weight, waist measurement and body fat percentage, we will also take a blood sample to measure HbA1c and cholesterol, all of which will help confirm that this participant is eligible to continue in this study (some may be excluded based on results of the above). We will also measure the amount of energy participants expend per minute while at rest and during a slow walking task (3km.h on a treadmill) using a gas mask technique. Energy responses to sitting and walking differ between individuals, therefore it is of interest to observe how each participant in this study responds to these conditions as it may help explain any potential findings of this study. For instance, introducing walking breaks (by way of reducing sitting time) may only benefit those who have consequent increases in energy expenditure as a result of these breaks. Lastly, to mark the end of the first study visit, participants will be asked to perform an exercise test based on a treadmill to assess their fitness level. whilst running a special mask covering the nose and mouth will be worn to analyse breathing, this will be connected to a machine (gas analyser) that gives information on the amount of oxygen participants breathe in and out. The point at which the amount of oxygen they breathe in remains stable despite increases in exercise difficulty is the point that we will stop the exercise test because this tells us that they have reached their exercise capacity (called V02max), and from this we can determine fitness level.
Following this first visit we will have fitness level data from all participants. Recruiting participants with a diverse fitness level will then help to elucidate the role that an individuals fitness has on their response to the following treatment conditions.
Treatment condition A is referred to as the 'sitting' condition. Here participants will remain seated throughout the whole of the 7 ½ hour test period (8am - 3:30pm) whilst watching TV/DVD's, reading, using the internet, doing paperwork etc. at their will. On arrival, participants will have a cannula (a small tube that allows us to take blood) inserted into their arm; this will stay in the arm and allow us to take regular blood samples throughout the day, without the need for multiple needles. After we take the first blood sample, participants will sit quietly for an hour. We will then provide breakfast. Whilst sitting, we will take blood samples (using the cannula) and blood pressure at 30, 60, 120 and 180 minutes after breakfast. We will then provide a lunch meal and will continue taking blood samples and blood pressure at 30, 60, 120, 180 and 210 minutes after this lunch meal. In total, we will take 11 blood samples over the 7 ½ hour testing period. Although this may sound a lot, it is equivalent to around 8-9 teaspoons of blood over the course of the day.
Condition B is the 'light activity breaks' condition. Participants will go through exactly the same process as condition A but will also be asked to do 5 minute bouts of slow walking on a treadmill every 30 minutes following breakfast and lunch. In total they will do 12 five minute walks on the treadmill throughout the 7 ½ hour test period (60 minutes of walking in total). In total, we will take 11 blood samples on the day.
With data on each participants metabolic response to a meal during A) prolonged sitting and B) during an interrupted sitting condition, we can see how fitness influenced the results.
However, at present, the absence of laboratory randomised crossover trials assessing the 'extent' to which fitness moderates the relationship between sedentary behaviour and metabolic health markers appear absent from the literature, warranting further investigation, which is why this design was chosen.
- Conditions
- Diabetes
- Being tested
- Prolonged sitting, Light activity breaks
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged sittingOther
Condition A is referred to as the 'sitting' condition. Here participants will remain seated throughout the whole of the 7 ½ hour test period (8am - 3:30pm). On arrival, participants will have a cannula (a small tube that allows us to take blood) inserted into their arm; this will stay in the arm and allow us to take regular blood samples throughout the day. Blood samples and blood pressure will be taken at 30, 60, 120 and 180 minutes after breakfast. We will then provide a lunch meal and will continue taking blood samples and blood pressure at 30, 60, 120, 180 and 210 minutes after this lunch meal. In total, we will take 11 blood samples over the 7 ½ hour testing period.
Light activity breaksOther
Condition B is the 'light activity breaks' condition. Participants will go through exactly the same process as condition A but will also be asked to do 5 minute bouts of slow walking on a treadmill every 30 minutes following breakfast and lunch. In total they will do 12 five minute walks on the treadmill throughout the 7 ½ hour test period (60 minutes of walking in total). In total, we will take 11 blood samples on the day.
| Study group | Role | What they receive |
|---|---|---|
| Prolonged sitting | Experimental | Not described Receives: Other: Prolonged sitting |
| Light activity breaks | Active comparator | Not described Receives: Other: Light activity breaks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose Area Under the Curve (AUC)
Blood glucose AUC refers to the spike of an individuals blood sugar following a meal, the aim of which is to reduce the spike and consequently reduce the area under the curve.
Measured: Assessed via 11 blood samples throughout each treatment condition throughout the 7.5 hour period
Secondary outcomes (3)
Blood Triglyceride AUC
Refers to an individuals triglyceride response to a meal over a prolonged time period during each treatment.
Measured: Assessed via 11 blood samples throughout each treatment condition throughout the 7.5 hour period
Insulin AUC
Refers to an individuals insulin response to a meal over a prolonged time period during each treatment.
Measured: Assessed via 11 blood samples throughout each treatment condition throughout the 7.5 hour period
Blood Pressure
Measured: Taken immediately before each blood sample is taken.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study startOct 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, National Health Service, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Thomas Yates, PhD, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493309
- Sponsor's protocol ID
- 0458
- Other IDs
- CRN151741
- Acronym
- FIT2SIT
- Status last verified
- Oct 2014
- First submitted
- 6 Jul 2015
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- 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 Impact of Cardio-respiratory Fitness on an Individual's Metabolic Response to Sitting and Light Activity Breaks
- ClinicalTrials.gov ID
- NCT02493309
- Acronym / sponsor ID
- FIT2SIT / 0458
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, National Health Service, United Kingdom
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 9 Jul 2015 (estimated)
- 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.
The purpose of this study is to determine whether an individuals cardio-respiratory fitness level can protect them from the negative metabolic impacts of prolonged sitting time.
Overall, it is hypothesised that in individuals with high fitness, the unfavourable effect of prolonged sitting (build up of sugar, fat and insulin in the blood following a meal) will not be as substantial, nor will light activity breaks be as advantageous, compared to individuals with lower fitness as they have a smaller scope for metabolic improvement.
Detailed description
The FIT 2 SIT study requires three separate study visits in total.
At visit one, we will check the participants blood pressure, height, weight, waist measurement and body fat percentage, we will also take a blood sample to measure HbA1c and cholesterol, all of which will help confirm that this participant is eligible to continue in this study (some may be excluded based on results of the above). We will also measure the amount of energy participants expend per minute while at rest and during a slow walking task (3km.h on a treadmill) using a gas mask technique. Energy responses to sitting and walking differ between individuals, therefore it is of interest to observe how each participant in this study responds to these conditions as it may help explain any potential findings of this study. For instance, introducing walking breaks (by way of reducing sitting time) may only benefit those who have consequent increases in energy expenditure as a result of these breaks. Lastly, to mark the end of the first study visit, participants will be asked to perform an exercise test based on a treadmill to assess their fitness level. whilst running a special mask covering the nose and mouth will be worn to analyse breathing, this will be connected to a machine (gas analyser) that gives information on the amount of oxygen participants breathe in and out. The point at which the amount of oxygen they breathe in remains stable despite increases in exercise difficulty is the point that we will stop the exercise test because this tells us that they have reached their exercise capacity (called V02max), and from this we can determine fitness level.
Following this first visit we will have fitness level data from all participants. Recruiting participants with a diverse fitness level will then help to elucidate the role that an individuals fitness has on their response to the following treatment conditions.
Treatment condition A is referred to as the 'sitting' condition. Here participants will remain seated throughout the whole of the 7 ½ hour test period (8am - 3:30pm) whilst watching TV/DVD's, reading, using the internet, doing paperwork etc. at their will. On arrival, participants will have a cannula (a small tube that allows us to take blood) inserted into their arm; this will stay in the arm and allow us to take regular blood samples throughout the day, without the need for multiple needles. After we take the first blood sample, participants will sit quietly for an hour. We will then provide breakfast. Whilst sitting, we will take blood samples (using the cannula) and blood pressure at 30, 60, 120 and 180 minutes after breakfast. We will then provide a lunch meal and will continue taking blood samples and blood pressure at 30, 60, 120, 180 and 210 minutes after this lunch meal. In total, we will take 11 blood samples over the 7 ½ hour testing period. Although this may sound a lot, it is equivalent to around 8-9 teaspoons of blood over the course of the day.
Condition B is the 'light activity breaks' condition. Participants will go through exactly the same process as condition A but will also be asked to do 5 minute bouts of slow walking on a treadmill every 30 minutes following breakfast and lunch. In total they will do 12 five minute walks on the treadmill throughout the 7 ½ hour test period (60 minutes of walking in total). In total, we will take 11 blood samples on the day.
With data on each participants metabolic response to a meal during A) prolonged sitting and B) during an interrupted sitting condition, we can see how fitness influenced the results.
However, at present, the absence of laboratory randomised crossover trials assessing the 'extent' to which fitness moderates the relationship between sedentary behaviour and metabolic health markers appear absent from the literature, warranting further investigation, which is why this design was chosen.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolonged sitting | Experimental | Other: Prolonged sitting |
| Light activity breaks | Active comparator | Other: Light activity breaks |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participant is willing and able to give informed consent for participation in the study
- Body Mass Index: 20 - 30 kg/m2
- Male and Female
- Aged: ≥ 25 to ≤ 55 years of age.
- Occupation: Work full-time in a predominantly sedentary occupation.
Key exclusion criteria (12 listed)
- Aged <25 or >55 years of age.
- 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
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 |
|---|---|---|
| Prolonged sittingCondition A is referred to as the 'sitting' condition. Here participants will remain seated throughout the whole of the 7 ½ hour test period (8am - 3:30pm). On arrival, participants will have a cannula (a small tube that allows us to take blood) inserted into their arm; this will stay in the arm and allow us to take regular blood samples throughout the day. Blood samples and blood pressure will be taken at 30, 60, 120 and 180 minutes after breakfast. We will then provide a lunch meal and will continue taking blood samples and blood pressure at 30, 60, 120, 180 and 210 minutes after this lunch meal. In total, we will take 11 blood samples over the 7 ½ hour testing period. | Other | Prolonged sitting |
| Light activity breaksCondition B is the 'light activity breaks' condition. Participants will go through exactly the same process as condition A but will also be asked to do 5 minute bouts of slow walking on a treadmill every 30 minutes following breakfast and lunch. In total they will do 12 five minute walks on the treadmill throughout the 7 ½ hour test period (60 minutes of walking in total). In total, we will take 11 blood samples on the day. | Other | Light activity breaks |
Primary outcome
Blood glucose Area Under the Curve (AUC)
Time frame: Assessed via 11 blood samples throughout each treatment condition throughout the 7.5 hour period
Blood glucose AUC refers to the spike of an individuals blood sugar following a meal, the aim of which is to reduce the spike and consequently reduce the area under the curve.
3 secondary outcomes
Blood Triglyceride AUC
Time frame: Assessed via 11 blood samples throughout each treatment condition throughout the 7.5 hour period
Insulin AUC
Time frame: Assessed via 11 blood samples throughout each treatment condition throughout the 7.5 hour period
Blood Pressure
Time frame: Taken immediately before each blood sample is taken.
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.
- NIHR Leicester-Loughborough Diet, Lifestyle and Physical Activity Biomedical Research UnitLink provided by the sponsor.
- Leicester Diabetes CentreLink provided by the sponsor.
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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.
Thomas Yates, PhD principal investigator
University of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged sitting and Light activity breaks in people with Diabetes, 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 5 inclusion and 12 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?
Blood glucose Area Under the Curve (AUC) (time frame: Assessed via 11 blood samples throughout each treatment condition throughout the 7.5 hour period). 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.