Sedentary BehaviorNCT04172090
Effects of Physical Inactivity on Insulin Sensitivity, Appetite, Energy Balance, and Cardiovascular Responses in Humans.
A study testing SIT+E and SIT=E in people with Sedentary Behavior, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Physical inactivity is a significant predictor of major non-communicable diseases such as type 2 diabetes (7%), cardiovascular disease (6%), musculoskeletal disorders and some cancers, and has been proposed to be the 4th leading cause of death worldwide. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior
- What is being tested?
- SIT+E and SIT=E
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Oct 2017to 13 Mar 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoking
- Males and females
- Age (18-35 years old)
- Body mass index (BMI) of 18-27 kg/m2
- Waist circumference <94cm for males and <80cm for females
- Ability to give informed consent
Who cannot join
- Smoking
- Any metabolic (e.g. diabetes), endocrine (e.g. hyperthyroidism) or cardiovascular (e.g. heart or blood) abnormalities including hypertension or heart failure
- Clinically significant abnormalities on screening including ECG abnormalities
- Taking routine medication that may alter cardiovascular function and blood flow (e.g. blood pressure-lowering drugs or drugs that cause hypertension)
- Well trained individuals with PAL>2.00; on an energy-restricted diet or seeking to lose weight
- High alcohol consumption (<3-4 units/d for men; <2-3 units/d for women)
- Females who are pregnant or lactating; self-reported allergy, intolerance or strong dislike of foods or drinks to be offered for the test breakfast, pasta meal or during the intervention period
- Beck Depression Inventory score >10 and Eating Attitudes Test (EAT-26) score >20 as self-reported markers of symptoms and concerns characteristic of depression and eating disorders, respectively.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-term Effects of Physical Inactivity on Insulin Sensitivity, Appetite, Energy Balance, and Cardiovascular Responses in Healthy Humans.
Physical inactivity is a significant predictor of major non-communicable diseases such as type 2 diabetes (7%), cardiovascular disease (6%), musculoskeletal disorders and some cancers, and has been proposed to be the 4th leading cause of death worldwide. Reduced physical activity leads to an impaired function of the hormone insulin and increased adiposity. Thus, the elimination of physical inactivity would remove between 6% and 10% of the major non-communicable diseases and increase life expectancy. The aim of the study is to investigate the effects of a short-term (2-day) period of reduced physical activity, with and without a proportional decrease in energy intake, on the action of insulin to regulate blood sugar fluctuations, appetite, and cardiovascular parameters (heart rate, cardiac output, stroke volume, blood flow, arterial blood pressure, peripheral vascular resistance) in response to food ingestion.
- Conditions
- Sedentary Behavior
- Being tested
- Control, SIT+E, SIT=E
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Normal physical activity and standard energy intake
SIT+EOther
Reduced physical activity and standard energy intake
SIT=EOther
Reduced physical activity and reduced energy intake
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | 2 consecutive days of standardised daily levels of moderate physical activity (PAL=1.85 reflecting their habitual levels), and matched energy (food) intake Receives: Other: Control |
| SIT+E | Experimental | 2 consecutive days of reduced physical activity induced by prolonged periods of sitting (PAL=1.4) whilst maintaining the level of food intake prescribed in the Control trial, thus creating a positive energy balance Receives: Other: SIT+E |
| SIT=E | Experimental | 2 consecutive days of reduced physical activity induced by prolonged periods of sitting (PAL=1.4) whilst reducing food intake to match the reduction in energy expenditure induced by inactivity, thus maintaining energy balance Receives: Other: SIT=E |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incremental area under curve for Insulin
The incremental area under curve for Insulin will be calculated using samples collected at 20 minute intervals between baseline and three hours
Measured: Over three hours from baseline
Secondary outcomes (1)
The incremental area under curve for arterialized whole blood glucose
The incremental area under curve for arterialized whole blood glucose will be calculated using samples collected at 10 minute intervals between baseline and four hours
Measured: Over four hours from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start20 Oct 2017
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
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 NottinghamThe 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172090
- Sponsor's protocol ID
- I200317
- Status last verified
- Nov 2019
- First submitted
- 19 Nov 2019
- Last updated
- 30 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only anonymised individual personal data will be shared, upon specific request from other researchers, for example, in order to undertake a meta analysis
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effects of Physical Inactivity on Insulin Sensitivity, Appetite, Energy Balance, and Cardiovascular Responses in Healthy Humans.
- ClinicalTrials.gov ID
- NCT04172090
- Acronym / sponsor ID
- I200317
- Conditions
- Sedentary Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 21 Nov 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.
Physical inactivity is a significant predictor of major non-communicable diseases such as type 2 diabetes (7%), cardiovascular disease (6%), musculoskeletal disorders and some cancers, and has been proposed to be the 4th leading cause of death worldwide. Reduced physical activity leads to an impaired function of the hormone insulin and increased adiposity. Thus, the elimination of physical inactivity would remove between 6% and 10% of the major non-communicable diseases and increase life expectancy. The aim of the study is to investigate the effects of a short-term (2-day) period of reduced physical activity, with and without a proportional decrease in energy intake, on the action of insulin to regulate blood sugar fluctuations, appetite, and cardiovascular parameters (heart rate, cardiac output, stroke volume, blood flow, arterial blood pressure, peripheral vascular resistance) in response to food ingestion.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: Control2 consecutive days of standardised daily levels of moderate physical activity (PAL=1.85 reflecting their habitual levels), and matched energy (food) intake |
| SIT+E | Experimental | Other: SIT+E2 consecutive days of reduced physical activity induced by prolonged periods of sitting (PAL=1.4) whilst maintaining the level of food intake prescribed in the Control trial, thus creating a positive energy balance |
| SIT=E | Experimental | Other: SIT=E2 consecutive days of reduced physical activity induced by prolonged periods of sitting (PAL=1.4) whilst reducing food intake to match the reduction in energy expenditure induced by inactivity, thus maintaining energy balance |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Non-smoking
- Males and females
- Age (18-35 years old)
- Body mass index (BMI) of 18-27 kg/m2
- Waist circumference <94cm for males and <80cm for females
Key exclusion criteria (8 listed)
- Smoking
- Any metabolic (e.g. diabetes), endocrine (e.g. hyperthyroidism) or cardiovascular (e.g. heart or blood) abnormalities including hypertension or heart failure
- Clinically significant abnormalities on screening including ECG abnormalities
- Taking routine medication that may alter cardiovascular function and blood flow (e.g. blood pressure-lowering drugs or drugs that cause hypertension)
- Well trained individuals with PAL>2.00; on an energy-restricted diet or seeking to lose weight
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 |
|---|---|---|
| ControlNormal physical activity and standard energy intake | Other | Control |
| SIT+EReduced physical activity and standard energy intake | Other | SIT+E |
| SIT=EReduced physical activity and reduced energy intake | Other | SIT=E |
Primary outcome
The incremental area under curve for Insulin
Time frame: Over three hours from baseline
The incremental area under curve for Insulin will be calculated using samples collected at 20 minute intervals between baseline and three hours
1 secondary outcome
The incremental area under curve for arterialized whole blood glucose
Time frame: Over four hours from baseline
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 Mar 2020.
- Individual participant dataSharing planned: No. only anonymised individual personal data will be shared, upon specific request from other researchers, for example, in order to undertake a meta analysis
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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 SIT+E and SIT=E in people with Sedentary Behavior, run by University of Nottingham 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 6 inclusion and 8 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 Mar 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?
The incremental area under curve for Insulin (time frame: Over three hours from baseline). 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 Mar 2020.