Metabolic SyndromeNCT03089437
The Effects of Prolonged Standing Compared to Prolonged Sitting on Postprandial Lipemia
A study testing Prolonged Standing and Prolonged Sitting in people with Metabolic Syndrome and Atherosclerosis, run by University of Texas at Austin at 1 site in United States.
Trial summary
The effects of 12 hours of prolonged standing will be compared to prolonged standing on a high fat tolerance test the following day. Plasma triglycerides, insulin, and glucose will be measured in a crossover study design. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Atherosclerosis
- What is being tested?
- Prolonged Standing and Prolonged Sitting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2017to 11 Aug 2018
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -
Who cannot join
- heart problems
- coronary artery disease
- hypertension
- respiratory problems
- musculoskeletal problems that prevent prolonged standing or sitting
- obesity
- susceptibility to fainting
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas at Austin Human Performance Laboratory
Austin, Texas, 78712
About this study
The effects of 12 hours of prolonged standing will be compared to prolonged standing on a high fat tolerance test the following day. Plasma triglycerides, insulin, and glucose will be measured in a crossover study design.
- Conditions
- Metabolic Syndrome, Atherosclerosis
- Being tested
- Prolonged Standing, Prolonged Sitting
- Medical subject headings
- Metabolic Syndrome, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged StandingBehavioural
Subject will stand for 12 hours and undergo a high fat tolerance test the subsequent day
Prolonged SittingBehavioural
Subject will sit for 12 hours and undergo a high fat tolerance test the subsequent day
| Study group | Role | What they receive |
|---|---|---|
| Prolonged Standing | Experimental | Subject stand for 12 hours. The following day the subject will undergo a high fat tolerance test. Order of sitting/standing will be random and each subject will perform both interventions. Receives: Behavioral: Prolonged Standing |
| Prolonged Sitting | Experimental | Subject sit for 12 hours. The following day the subject will undergo a high fat tolerance test. Order of sitting/standing will be random and each subject will perform both interventions. Receives: Behavioral: Prolonged Sitting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Triglycerides
The area under the curve for plasma triglycerides from hourly samples during a 6 hour high fat tolerance test
Measured: 6 hours
Plasma Insulin
The area under the curve for plasma insulin from hourly samples during a 6 hour high fat tolerance test
Measured: 6 hours
Plasma Glucose
The area under the curve for plasma glucose from hourly samples during a 6 hour high fat tolerance test
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start31 Mar 2017
- Primary completion11 Aug 2017
- Study completion11 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward F. Coyle, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089437
- Sponsor's protocol ID
- 2016-12-0031
- Status last verified
- Oct 2018
- First submitted
- 20 Mar 2017
- Last updated
- 4 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Prolonged Standing Compared to Prolonged Sitting on Postprandial Lipemia
- ClinicalTrials.gov ID
- NCT03089437
- Acronym / sponsor ID
- 2016-12-0031
- Conditions
- Metabolic Syndrome, Atherosclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 11 Aug 2017 (actual)
- Study completion
- 11 Aug 2018 (actual)
- First posted
- 24 Mar 2017 (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.
The effects of 12 hours of prolonged standing will be compared to prolonged standing on a high fat tolerance test the following day. Plasma triglycerides, insulin, and glucose will be measured in a crossover study design.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolonged Standing | Experimental | Behavioral: Prolonged StandingSubject stand for 12 hours. The following day the subject will undergo a high fat tolerance test. Order of sitting/standing will be random and each subject will perform both interventions. |
| Prolonged Sitting | Experimental | Behavioral: Prolonged SittingSubject sit for 12 hours. The following day the subject will undergo a high fat tolerance test. Order of sitting/standing will be random and each subject will perform both interventions. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (7 listed)
- heart problems
- coronary artery disease
- hypertension
- respiratory problems
- musculoskeletal problems that prevent prolonged standing or 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 |
|---|---|---|
| Prolonged StandingSubject will stand for 12 hours and undergo a high fat tolerance test the subsequent day | Behavioural | Prolonged Standing |
| Prolonged SittingSubject will sit for 12 hours and undergo a high fat tolerance test the subsequent day | Behavioural | Prolonged Sitting |
Primary outcome
Plasma Triglycerides
Time frame: 6 hours
The area under the curve for plasma triglycerides from hourly samples during a 6 hour high fat tolerance test
Plasma Insulin
Time frame: 6 hours
The area under the curve for plasma insulin from hourly samples during a 6 hour high fat tolerance test
Plasma Glucose
Time frame: 6 hours
The area under the curve for plasma glucose from hourly samples during a 6 hour high fat tolerance test
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 4 Oct 2018.
- Individual participant dataSharing planned: No
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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 Prolonged Standing and Prolonged Sitting in people with Metabolic Syndrome and Atherosclerosis, run by University of Texas at Austin 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 1 inclusion and 7 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 4 Oct 2018. 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. 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?
Plasma Triglycerides (time frame: 6 hours). The study lists 3 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 4 Oct 2018.