DiabetesPhase 3NCT02616809
Effects of Standing and Light-intensity Activity on Ambulatory Blood Pressure and Blood Glucose
A Phase 3 study testing Maintaining posture and energy expenditure, Increasing energy expenditure and Changing posture in people with Diabetes and Hypertension, run by Arizona State University.
Trial summary
This study aims to test the short-term effects of intermittent standing, slow cycling and slow walking, compared to sitting, on continuous blood glucose and ambulatory blood pressure among pre-hypertensive and pre-diabetic adults. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Hypertension, Sleep
- What is being tested?
- Maintaining posture and energy expenditure, Increasing energy expenditure and Changing posture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Apr 2015
- Phase
- Phase 3
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- pre-hypertensive (systolic blood pressure 120-139 mmHg, or diastolic blood pressure 80-89 mmHg)
- impaired fasting glucose (5.6-6.9 mmil/L)
- not meeting the physical activity guidelines for adults (>=150 min/wk of moderate-to-vigorous physical activity)
Who cannot join
- smoking, pregnancy, known coronary heart disease, orthopedic limitations for performing physical activity, taking medications to control high blood pressure or high blood glucose, special dietary requirements, and being advised by a doctor to avoid prolonged periods of sitting.
About this study
This study aims to test the short-term effects of intermittent standing, slow cycling and slow walking, compared to sitting, on continuous blood glucose and ambulatory blood pressure among pre-hypertensive and pre-diabetic adults.
Read the detailed description
This study will enroll 10 adults who will each complete four experimental conditions in random order. Each of the four experimental conditions are as follows: 1) sit continuously for 8 hours in a simulated office environment, 2) break-up sitting time with standing based on set hourly intervals, 3) break-up sitting time with slow-walking on a treadmill desk based on set hourly intervals, 4) increase energy expenditure by slow cycling based on set hourly intervals. Participants will completed each condition one week apart and dietary intake will be standardized by giving participants the same meals during each intervention condition. Study measures will include: anthropometrics (height and weight), blood pressure, fasting glucose, 24-continuous glucose monitoring, full-day ambulatory blood pressure monitoring, cognitive testing (cognitive performance), energy expenditure, physical activity via accelerometer, sleep via accelerometer, and heart rate.
- Conditions
- Diabetes, Hypertension, Sleep
- Being tested
- Maintaining posture and energy expenditure, Increasing energy expenditure, Changing posture, Increasing energy expenditure and changing posture
- Medical subject headings
- Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maintaining posture and energy expenditureOther
Participants will sit continuously for 8-hrs during a simulated office environment
Increasing energy expenditureOther
Participants will cycle slowly while seated in prescribed hourly intervals. This condition will increase energy expenditure while keeping a sitting posture
Changing postureOther
Participants will transition from sitting to standing in prescribed hourly intervals. This condition will change posture (sit to stand) while maintaining low energy expenditure
Increasing energy expenditure and changing postureOther
Participants will transition from sitting to a walking workstation in prescribed hourly intervals. This condition will both increase energy expenditure and change posture.
| Study group | Role | What they receive |
|---|---|---|
| Sitting | Experimental | Participants will sit continuously for 8 hours in a simulated office environment Receives: Other: Maintaining posture and energy expenditure |
| slow cycling | Experimental | Participants will cycle at regular hourly intervals during an 8-hr simulated office environment Receives: Other: Increasing energy expenditure |
| standing | Experimental | Participants will change posture (from sitting to standing) during hourly intervals for an 8-hr period in a simulated office environment Receives: Other: Changing posture |
| slow walking | Experimental | Participants will transition from sitting to slow walking on a treadmill desk at regular hourly intervals during an 8-hr period in a simulated office environment Receives: Other: Increasing energy expenditure and changing posture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of change in blood pressure following changes in posture and increasing energy expenditure
Measured: single-day intervention
Evidence of change in blood glucose following changes in posture and increasing energy expenditure
Measured: single-day intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2015 (estimated)
- Study startJul 2014
- Primary completionApr 2015
- Study completionApr 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.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noe Crespo, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02616809
- Sponsor's protocol ID
- 1306009298
- Status last verified
- Nov 2015
- First submitted
- 24 Nov 2015
- Last updated
- 30 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Standing and Light-intensity Activity on Ambulatory Blood Pressure and Blood Glucose
- ClinicalTrials.gov ID
- NCT02616809
- Acronym / sponsor ID
- 1306009298
- Conditions
- Diabetes, Hypertension, Sleep
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 30 Nov 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.
This study aims to test the short-term effects of intermittent standing, slow cycling and slow walking, compared to sitting, on continuous blood glucose and ambulatory blood pressure among pre-hypertensive and pre-diabetic adults.
Detailed description
This study will enroll 10 adults who will each complete four experimental conditions in random order. Each of the four experimental conditions are as follows: 1) sit continuously for 8 hours in a simulated office environment, 2) break-up sitting time with standing based on set hourly intervals, 3) break-up sitting time with slow-walking on a treadmill desk based on set hourly intervals, 4) increase energy expenditure by slow cycling based on set hourly intervals. Participants will completed each condition one week apart and dietary intake will be standardized by giving participants the same meals during each intervention condition. Study measures will include: anthropometrics (height and weight), blood pressure, fasting glucose, 24-continuous glucose monitoring, full-day ambulatory blood pressure monitoring, cognitive testing (cognitive performance), energy expenditure, physical activity via accelerometer, sleep via accelerometer, and heart rate.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sitting | Experimental | Other: Maintaining posture and energy expenditureParticipants will sit continuously for 8 hours in a simulated office environment |
| slow cycling | Experimental | Other: Increasing energy expenditureParticipants will cycle at regular hourly intervals during an 8-hr simulated office environment |
| standing | Experimental | Other: Changing postureParticipants will change posture (from sitting to standing) during hourly intervals for an 8-hr period in a simulated office environment |
| slow walking | Experimental | Other: Increasing energy expenditure and changing postureParticipants will transition from sitting to slow walking on a treadmill desk at regular hourly intervals during an 8-hr period in a simulated office environment |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- pre-hypertensive (systolic blood pressure 120-139 mmHg, or diastolic blood pressure 80-89 mmHg)
- impaired fasting glucose (5.6-6.9 mmil/L)
- not meeting the physical activity guidelines for adults (>=150 min/wk of moderate-to-vigorous physical activity)
Key exclusion criteria (1 listed)
- smoking, pregnancy, known coronary heart disease, orthopedic limitations for performing physical activity, taking medications to control high blood pressure or high blood glucose, special dietary requirements, and being advised by a doctor to avoid prolonged periods of sitting.
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 |
|---|---|---|
| Maintaining posture and energy expenditureParticipants will sit continuously for 8-hrs during a simulated office environment | Other | Sitting |
| Increasing energy expenditureParticipants will cycle slowly while seated in prescribed hourly intervals. This condition will increase energy expenditure while keeping a sitting posture | Other | slow cycling |
| Changing postureParticipants will transition from sitting to standing in prescribed hourly intervals. This condition will change posture (sit to stand) while maintaining low energy expenditure | Other | standing |
| Increasing energy expenditure and changing postureParticipants will transition from sitting to a walking workstation in prescribed hourly intervals. This condition will both increase energy expenditure and change posture. | Other | slow walking |
Primary outcome
Evidence of change in blood pressure following changes in posture and increasing energy expenditure
Time frame: single-day intervention
Evidence of change in blood glucose following changes in posture and increasing energy expenditure
Time frame: single-day intervention
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 Nov 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Maintaining posture and energy expenditure, Increasing energy expenditure and Changing posture in people with Diabetes and Hypertension, run by Arizona State University.
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 3 inclusion and 1 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 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Evidence of change in blood pressure following changes in posture and increasing energy expenditure (time frame: single-day intervention). The study lists 2 primary outcomes in all. 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 Nov 2015.