PrediabetesNCT01884792
Effects of Standing on Glycemia in Prediabetic Adults
A study testing Sitting OGTT, Standing OGTT and Sitting CGM in people with Prediabetes, run by University of Minnesota at 1 site in United States.
Trial summary
The study is a crossover, pilot trial examining the acute effects of standing on blood sugar in prediabetic, working adults. Participants will complete oral glucose tolerance testing, once while sitting and once while standing. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetes
- What is being tested?
- Sitting OGTT, Standing OGTT and Sitting CGM
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Sep 2013
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fasting blood glucose >100 mg/dl
- Employed full-time working at least 35 hours/week
- Able to safely begin a light physical activity program
Who cannot join
- Heart disease
- Renal disease
- Peripheral neuropathy
- Retinopathy
- PAD
- Lower limb amputation
Show all 14Show fewer
- pregnancy
- active substance abuse
- current smoker
- psychiatric disorder
- severe visual impairment
- immune-compromised individuals,
- enrollment in a physical activity study
- use of insulin or an insulin pump
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Human Services
Saint Paul, Minnesota, 55155
About this study
Official title: Acute Effects of Standing on Glycemia in Prediabetic Adults: A Pilot Study
The study is a crossover, pilot trial examining the acute effects of standing on blood sugar in prediabetic, working adults. Participants will complete oral glucose tolerance testing, once while sitting and once while standing. They will also wear a continuous blood sugar monitor once while sitting at their desk for a week and once while using their desk as a sit-stand desk with a goal of standing intermittently for at least half of the work day. Physical activity levels will be measured with an accelerometer. The primary study hypothesis is that blood sugar will differ between the sitting and standing conditions for each of the tests performed.
- Conditions
- Prediabetes
- Being tested
- Sitting OGTT, Standing OGTT, Sitting CGM, Standing CGM
- Keywords
- prediabetes, physical inactivity, sedentary, standing
- Medical subject headings
- Prediabetic State, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sitting OGTTOther
Standing OGTTOther
Sitting CGMOther
Standing CGMOther
| Study group | Role | What they receive |
|---|---|---|
| Sitting Oral Glucose Tolerance Test | Placebo comparator | An OGTT is performed while the subject sits at their desk for the entire 2-hour period. 5 blood sugar measurements are taken and a 75g dextrose beverage is consumed following the first, baseline blood sugar reading. The blood sugar is then measured every 30 minutes up to 120 min. Receives: Other: Sitting OGTT; Other: Standing OGTT |
| Standing Oral Glucose Tolerance Test | Experimental | The participant stands at their desk for the duration of the 2-hour blood sugar test. The same procedure is performed as in the sitting condition. Receives: Other: Sitting OGTT; Other: Standing OGTT |
| Sitting Continuous Glucose Monitor | Placebo comparator | A continuous blood glucose monitor is worn for 5 days while at work. In the sitting condition the participant only sits at their desk for the duration of the week. Blood sugar is monitored 4 times per day to calibrate the CGM and an accelerometer is worn to track physical activity. Receives: Other: Sitting CGM; Other: Standing CGM |
| Standing Continuous Glucose Monitor | Experimental | Participants are instructed to stand intermittently for at least half of their work day during this 5 day period. Blood sugar is monitored and physical activity is tracked with an accelerometer. Receives: Other: Sitting CGM; Other: Standing CGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood sugar area under the curve
The area under the curve following the 2 hour blood sugar tests.
Measured: 2 hours
Secondary outcomes (1)
Accelerometer counts
Accelerometer counts in the 4 testing conditions.
Measured: 4 hours and 2 5 day periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startMar 2013
- Primary completionJul 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884792
- Sponsor's protocol ID
- 1208M18741
- Status last verified
- Sep 2014
- First submitted
- 19 Jun 2013
- Last updated
- 15 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Standing on Glycemia in Prediabetic Adults: A Pilot Study
- ClinicalTrials.gov ID
- NCT01884792
- Acronym / sponsor ID
- 1208M18741
- Conditions
- Prediabetes
- Keywords
- prediabetes, physical inactivity, sedentary, standing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Mayo Clinic
- Study start
- Mar 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 24 Jun 2013 (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 study is a crossover, pilot trial examining the acute effects of standing on blood sugar in prediabetic, working adults. Participants will complete oral glucose tolerance testing, once while sitting and once while standing. They will also wear a continuous blood sugar monitor once while sitting at their desk for a week and once while using their desk as a sit-stand desk with a goal of standing intermittently for at least half of the work day. Physical activity levels will be measured with an accelerometer. The primary study hypothesis is that blood sugar will differ between the sitting and standing conditions for each of the tests performed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sitting Oral Glucose Tolerance Test | Placebo comparator | Other: Sitting OGTT, Other: Standing OGTTAn OGTT is performed while the subject sits at their desk for the entire 2-hour period. 5 blood sugar measurements are taken and a 75g dextrose beverage is consumed following the first, baseline blood sugar reading. The blood sugar is then measured every 30 minutes up to 120 min. |
| Standing Oral Glucose Tolerance Test | Experimental | Other: Sitting OGTT, Other: Standing OGTTThe participant stands at their desk for the duration of the 2-hour blood sugar test. The same procedure is performed as in the sitting condition. |
| Sitting Continuous Glucose Monitor | Placebo comparator | Other: Sitting CGM, Other: Standing CGMA continuous blood glucose monitor is worn for 5 days while at work. In the sitting condition the participant only sits at their desk for the duration of the week. Blood sugar is monitored 4 times per day to calibrate the CGM and an accelerometer is worn to track physical activity. |
| Standing Continuous Glucose Monitor | Experimental | Other: Sitting CGM, Other: Standing CGMParticipants are instructed to stand intermittently for at least half of their work day during this 5 day period. Blood sugar is monitored and physical activity is tracked with an accelerometer. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fasting blood glucose >100 mg/dl
- Employed full-time working at least 35 hours/week
- Able to safely begin a light physical activity program
Key exclusion criteria (14 listed)
- Heart disease
- Renal disease
- Peripheral neuropathy
- Retinopathy
- PAD
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 |
|---|---|---|
| Sitting OGTT | Other | Sitting Oral Glucose Tolerance Test, Standing Oral Glucose Tolerance Test |
| Standing OGTT | Other | Sitting Oral Glucose Tolerance Test, Standing Oral Glucose Tolerance Test |
| Sitting CGM | Other | Sitting Continuous Glucose Monitor, Standing Continuous Glucose Monitor |
| Standing CGM | Other | Sitting Continuous Glucose Monitor, Standing Continuous Glucose Monitor |
Primary outcome
Blood sugar area under the curve
Time frame: 2 hours
The area under the curve following the 2 hour blood sugar tests.
1 secondary outcome
Accelerometer counts
Time frame: 4 hours and 2 5 day periods
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 15 Sep 2014.
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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 Sitting OGTT, Standing OGTT and Sitting CGM in people with Prediabetes, run by University of Minnesota at 1 site in United States.
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 14 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 15 Sep 2014. 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 States. 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. Some participants in this study may receive a placebo. 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 sugar area under the curve (time frame: 2 hours). 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 15 Sep 2014.