Sedentary BehaviorNCT04195165
The Effect of Sitting and Moderate Exercise on Plasma Insulin and Glucose Responses to an Oral Glucose Tolerance Test
A study testing SIT, ACTIVE and EX in people with Sedentary Behavior and Insulin Sensitivity, run by University of Texas at Austin at 1 site in United States.
Trial summary
The investigators hypothesize that cycling for 1 hour of exercise at 65% peak oxygen consumption (VO2peak) after sitting >13 hr/day (SIT+EX) will not be different in postprandial plasma insulin responses compared to the control of only sitting (SIT). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior, Insulin Sensitivity, Sedentary Lifestyle
- What is being tested?
- SIT, ACTIVE and EX
- Type of treatment
- Pill or oral medicine, 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
- 23 Sep 2019to 23 Sep 2020
- 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
- Healthy, untrained/recreationally active men and women.
- Women must not be pregnant or post-menopausal.
Who cannot join
- Heart problems or coronary artery disease
- Hypertension
- Lung or respiratory problems
- Chest pain, fainting, or heart palpitations during exercise, or told to give up sports because of health problems.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Texas at Austin
Austin, Texas, 78712
Michael B Dial, 801-891-5699, michael.dial@utexas.edu
About this study
The investigators hypothesize that cycling for 1 hour of exercise at 65% peak oxygen consumption (VO2peak) after sitting >13 hr/day (SIT+EX) will not be different in postprandial plasma insulin responses compared to the control of only sitting (SIT). Furthermore, the investigators hypothesize that the SIT and SIT+EX groups will have a less favorble insulin response compared to the physically active group after performing the same 1-hour exercise bout (ACTIVE+EX).
Read the detailed description
Twelve healthy, untrained male and female participants will complete three different trials in a randomized, crossover design, each occurring over 4 days with a 3-4 day interval between the trials. Each trial consists of 3 phases. The first two days will serve as a control phase (C1) that will allow for familiarization, followed by a 2-day intervention phase consisting of 2 days of sitting 13 h/d for both groups (D1- D2) (SIT+EX and ACTIVE+EX). On the evening of Day 2 the SIT+EX and ACTIVE+EX groups will cycle for 1 hour at 65% of VO2peak. On the morning of Day 3 participants in all conditions will ingest a drink containing 75-g of glucose and undergo a two-hour oral glucose tolerance test (OGTT). For all trials, participants will refrain from any exercise other than that described for the study.
One week prior to the initiation of the first trial, participants will visit the Human Performance Laboratory (HPL) for a 10 min exercise test to measure peak oxygen uptake while cycling (VO2peak). On the same day, participants will be instrumented with an activity monitor worn on their thigh to record time sitting, standing and lying as well as step count (activPal). During the two control day (C1), participants will be asked to refrain from any planned exercise but will be asked to walk or move between 6,000 - 7,500 steps per day, which is considered to be 'low level of physical activity'(31). During the intervention days (D1-D2), those completing SIT and SIT+EX conditions will be asked to remain seated throughout much of the day and achieve <3,000 steps, while those completing the ACTIVE+EX condition will be asked to break up their sitting with low-intensity physical activity, not exercise, and achieve >10,000 steps. However, the only difference between trials is that at 18:00 h during SIT+EX and ACTIVE+EX they will cycle for 1-hr at 65% VO2peak.
On the day of the OGTT (D3), participants will report to the laboratory at 07:00 h. Body weight will be measured. They will lay down for 5 minutes and a catheter will be inserted into an antecubital vein and a fasting blood sample will then be collected 10 min before consumption of high-glucose drink (75 g) composed of water and glucose monohydrate. Approximately 5 ml of blood will be collected at 10, 20, 30, 60, 90 and 120 min after ingestion. Approximately 60 ml of blood will be sampled during each of the three trials and thus the total will amount to approximately 180 ml (6 ounces, 12 tablespoons). This amounts to approximately 2-4% of a person's total blood volume.
All blood samples collected will be transferred to K2 EDTA collection tubes, centrifuged at 2,000 g for 15 minutes at 4◦C and then stored in -80◦C freezer until later analysis. During OGTT, participants will sit quietly reading, watching movies, and/or surfing the Internet. Participants will also be asked to keep a consistent sleep/wake cycle during the trials.
- Conditions
- Sedentary Behavior, Insulin Sensitivity, Sedentary Lifestyle
- Being tested
- SIT, ACTIVE, EX
- Keywords
- glucose tolerance, exercise, insulin sensitivity
- Medical subject headings
- Sedentary Behavior, Insulin Resistance, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SITBehavioural
For the SIT and SIT+EX conditions, the subject will be asked to take <3,000 steps. This is meant to achieve ~12-13 hours of sitting per day, are the investigators are measuring the effect of inactivity and exercise on insulin sensitivity.
ACTIVEBehavioural
For the ACTIVE+EX condition, the subject will be asked to take >10,000 steps for the two intervention days. This is meant to simulate an active lifestyle.
EXBehavioural
Also called Exercise
The SIT+EX and ACTIVE+EX conditions will include an exercise bout on the evening of the second intervention day, and have the oral glucose tolerance test the next morning.
| Study group | Role | What they receive |
|---|---|---|
| SIT | Experimental | Subject will be asked to take <3,000 steps for two intervention days prior to an oral glucose tolerance test on the third day. Receives: Behavioral: SIT |
| SIT+EX | Experimental | Subject will be asked to take <3,000 steps for two intervention days. On the evening of the second intervention day, the subject will cycle for one hour at 65% of VO2peak. The subject will undergo an oral glucose tolerance test on the morning of the third day. Receives: Behavioral: SIT; Behavioral: EX |
| ACTIVE+EX | Experimental | Subject will be asked to take >10,000 steps for two intervention days. On the evening of the second intervention day, the subject will cycle for one hour at 65% of VO2peak. The subject will undergo an oral glucose tolerance test on the morning of the third day. Receives: Behavioral: ACTIVE; Behavioral: EX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
The investigators will measure glucose and insulin levels from data collected during the oral glucose tolerance test.
Measured: Up to 4 weeks after data completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start23 Sep 2019
- Primary completion30 Jun 2020 (estimated)
- Study completion23 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviorStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael B. Dial, University of Texas at Austin
- Investigators
- Michael B Dial, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195165
- Sponsor's protocol ID
- 2019-08-0011
- Status last verified
- Dec 2019
- First submitted
- 24 Sep 2019
- Last updated
- 11 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sitting and Moderate Exercise on Plasma Insulin and Glucose Responses to an Oral Glucose Tolerance Test
- ClinicalTrials.gov ID
- NCT04195165
- Acronym / sponsor ID
- 2019-08-0011
- Conditions
- Sedentary Behavior, Insulin Sensitivity, Sedentary Lifestyle
- Keywords
- glucose tolerance, exercise, insulin sensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 23 Sep 2020 (estimated)
- First posted
- 11 Dec 2019 (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 investigators hypothesize that cycling for 1 hour of exercise at 65% peak oxygen consumption (VO2peak) after sitting >13 hr/day (SIT+EX) will not be different in postprandial plasma insulin responses compared to the control of only sitting (SIT). Furthermore, the investigators hypothesize that the SIT and SIT+EX groups will have a less favorble insulin response compared to the physically active group after performing the same 1-hour exercise bout (ACTIVE+EX).
Detailed description
Twelve healthy, untrained male and female participants will complete three different trials in a randomized, crossover design, each occurring over 4 days with a 3-4 day interval between the trials. Each trial consists of 3 phases. The first two days will serve as a control phase (C1) that will allow for familiarization, followed by a 2-day intervention phase consisting of 2 days of sitting 13 h/d for both groups (D1- D2) (SIT+EX and ACTIVE+EX). On the evening of Day 2 the SIT+EX and ACTIVE+EX groups will cycle for 1 hour at 65% of VO2peak. On the morning of Day 3 participants in all conditions will ingest a drink containing 75-g of glucose and undergo a two-hour oral glucose tolerance test (OGTT). For all trials, participants will refrain from any exercise other than that described for the study.
One week prior to the initiation of the first trial, participants will visit the Human Performance Laboratory (HPL) for a 10 min exercise test to measure peak oxygen uptake while cycling (VO2peak). On the same day, participants will be instrumented with an activity monitor worn on their thigh to record time sitting, standing and lying as well as step count (activPal). During the two control day (C1), participants will be asked to refrain from any planned exercise but will be asked to walk or move between 6,000 - 7,500 steps per day, which is considered to be 'low level of physical activity'(31). During the intervention days (D1-D2), those completing SIT and SIT+EX conditions will be asked to remain seated throughout much of the day and achieve <3,000 steps, while those completing the ACTIVE+EX condition will be asked to break up their sitting with low-intensity physical activity, not exercise, and achieve >10,000 steps. However, the only difference between trials is that at 18:00 h during SIT+EX and ACTIVE+EX they will cycle for 1-hr at 65% VO2peak.
On the day of the OGTT (D3), participants will report to the laboratory at 07:00 h. Body weight will be measured. They will lay down for 5 minutes and a catheter will be inserted into an antecubital vein and a fasting blood sample will then be collected 10 min before consumption of high-glucose drink (75 g) composed of water and glucose monohydrate. Approximately 5 ml of blood will be collected at 10, 20, 30, 60, 90 and 120 min after ingestion. Approximately 60 ml of blood will be sampled during each of the three trials and thus the total will amount to approximately 180 ml (6 ounces, 12 tablespoons). This amounts to approximately 2-4% of a person's total blood volume.
All blood samples collected will be transferred to K2 EDTA collection tubes, centrifuged at 2,000 g for 15 minutes at 4◦C and then stored in -80◦C freezer until later analysis. During OGTT, participants will sit quietly reading, watching movies, and/or surfing the Internet. Participants will also be asked to keep a consistent sleep/wake cycle during the trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SIT | Experimental | Behavioral: SITSubject will be asked to take <3,000 steps for two intervention days prior to an oral glucose tolerance test on the third day. |
| SIT+EX | Experimental | Behavioral: SIT, Behavioral: EXSubject will be asked to take <3,000 steps for two intervention days. On the evening of the second intervention day, the subject will cycle for one hour at 65% of VO2peak. The subject will undergo an oral glucose tolerance test on the morning of the third day. |
| ACTIVE+EX | Experimental | Behavioral: ACTIVE, Behavioral: EXSubject will be asked to take >10,000 steps for two intervention days. On the evening of the second intervention day, the subject will cycle for one hour at 65% of VO2peak. The subject will undergo an oral glucose tolerance test on the morning of the third day. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy, untrained/recreationally active men and women.
- Women must not be pregnant or post-menopausal.
Key exclusion criteria (4 listed)
- Heart problems or coronary artery disease
- Hypertension
- Lung or respiratory problems
- Chest pain, fainting, or heart palpitations during exercise, or told to give up sports because of health problems.
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 |
|---|---|---|
| SITFor the SIT and SIT+EX conditions, the subject will be asked to take <3,000 steps. This is meant to achieve ~12-13 hours of sitting per day, are the investigators are measuring the effect of inactivity and exercise on insulin sensitivity. | Behavioural | SIT, SIT+EX |
| ACTIVEFor the ACTIVE+EX condition, the subject will be asked to take >10,000 steps for the two intervention days. This is meant to simulate an active lifestyle. | Behavioural | ACTIVE+EX |
| EXAlso: ExerciseThe SIT+EX and ACTIVE+EX conditions will include an exercise bout on the evening of the second intervention day, and have the oral glucose tolerance test the next morning. | Behavioural | ACTIVE+EX, SIT+EX |
Primary outcome
Insulin sensitivity
Time frame: Up to 4 weeks after data completion
The investigators will measure glucose and insulin levels from data collected during the oral glucose tolerance test.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- 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.
Michael B Dial principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIT, ACTIVE and EX in people with Sedentary Behavior and Insulin Sensitivity, 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 Dec 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael B Dial (8018915699, Michael.dial@utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: Up to 4 weeks after data completion). 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 11 Dec 2019.