OverweightNCT01299311
NEAT and Insulin Sensitivity
A study testing NEAT and Exercise in people with Overweight, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The effect of Non-Exercise Activity Thermogenesis (NEAT) or inactivity on insulin sensitivity and lipid metabolism is unclear. Research recently published shows that activities associated with everyday activities, summarized as NEAT, such as walking and standing, have a much greater role in energy expenditure than… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- NEAT and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2010to Jul 2011
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18-30 years old
- BMI between 25.0-30.0 kg/m2
- Sedentary, defined as maximum of exercise of 1 hour/week and less than 2x/week
Who cannot join
- Cardiovascular disease
- Diabetes mellitus type 1 or 2 or fasting glucose > 6.9 mmol/L
- Other diseases that make physical activity difficult
- Alcohol > 2 consumptions/day
- Illegal drug use and cannabis use
- Medication use, other than contraception
- Triglycerides > 3.0 mmol/L
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center/ University of Maastricht
Maastricht, 6202 AZ
About this study
Official title: The Effect of Activity on Insulin Sensitivity and Lipid Metabolism in Sedentary, Overweight People.
The effect of Non-Exercise Activity Thermogenesis (NEAT) or inactivity on insulin sensitivity and lipid metabolism is unclear. Research recently published shows that activities associated with everyday activities, summarized as NEAT, such as walking and standing, have a much greater role in energy expenditure than exercise. Therefore, the objective of the present study is to evaluate the effect of 4 days of inactivity (mainly sitting), 4 days of everyday activities (sitting, walking and standing), and 4 days of inactivity and exercise (sitting and biking) on glucose metabolism and insulin sensitivity using an oral glucose tolerance test, and on lipid metabolism in sedentary, overweight people. The investigators hypothesize that:
- 4 days of everyday activities (NEAT) will cause an increased glucose tolerance and increased insulin sensitivity compared to 4 days of inactivity in sedentary, overweight people.
- 4 days of exercise will improve glucose tolerance and insulin sensitivity more than 4 days of NEAT with equal energy expenditure, in sedentary, overweight people.
- Fasting triglyceride will have the same course as glucose, mentioned in 1. and 2.
Read the detailed description
To evaluate the effect of Non-Exercise Activity Thermogenesis (NEAT) on glucose and lipid metabolism in sedentary, overweight people, the subjects included in the study protocol will follow 3 times a certain activity program of 4 days. These activity programs are:
- Inactivity: 14 hours of sitting, 2 hours of everyday activities, 8 hours of sleeping or laying down per day.
- NEAT: 4 hours of walking, 8 hours of sitting, 2 hours of standing, 2 hours of everyday activities, 8 hours of sleeping or laying down per day.
- Exercise: 1 hour biking, 13 hours of sitting, 2 hours of everyday activities, 8 hours of sleeping or laying down per day.
The subjects will be biking using a home trainer, measuring energy expenditure, and supervised by one of the members of the research team. They will bike until they have reached a certain amount of kCal. The subjects will wear two accelerometers during all 3 activity programs to evaluate the amount of each activity (sitting, walking, standing, laying/sleeping). The Computer Science and Applications (CSA) Actigraph accelerometer will be placed on the back and the Continuous Activity Monitor (CAM) Maastricht instrument on the leg. Furthermore, the subjects will be requested to note their activities and dietary intake in a diary. After every 4 days of each activity program, an oral glucose tolerance test will be performed in the morning (fasting state) of the next day (day 5). Before and 15, 30, 45, 60, 90, 120 minutes after ingestion of 75 gram of glucose in water, blood will be drawn for measurements of glucose and insulin. Only at baseline (t=0 minutes), blood will be drawn to measure cholesterol, HDL, LDL, triglycerides, apoA and apoB.
- Conditions
- Overweight
- Being tested
- NEAT, Exercise
- Keywords
- insulin sensitivity
- Medical subject headings
- Overweight, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEATBehavioural
4 days of everyday activities, including 4 hours of walking, 8 hours of sitting, 2 hours of standing, 2 hours of everyday activities and 8 hours of sleeping or laying down per day
ExerciseBehavioural
4 days of activity program, including 1 hour biking (exercise), 13 hours of sitting, 2 hours of everyday activities and 8 hours of sleeping or laying down per day
| Study group | Role | What they receive |
|---|---|---|
| Inactivity | No intervention | 4 days of inactivity, mainly sitting |
| NEAT | Active comparator | 4 days of NEAT (everyday activities) Receives: Behavioral: NEAT |
| Exercise | Active comparator | 4 days of inactivity combined with 1 hour of exercise Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin sensitivity after 4 days of NEAT compared to 4 days of inactivity and compared to 4 days of exercise
Change in insulin sensitivity measured using oral glucose tolerance test
Measured: day 5
Secondary outcomes (1)
Change in fasting triglycerides after 4 days of NEAT compared to 4 days of inactivity and compared to 4 days of exercise
Measured: 5 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startDec 2010
- Primary completionJun 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolaas C Schaper, Prof., MD, Principal investigator, Maastricht University Medical Center/ University of Maastricht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01299311
- Sponsor's protocol ID
- MEC 10-2-057
- Status last verified
- Jul 2012
- First submitted
- 17 Jan 2011
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Activity on Insulin Sensitivity and Lipid Metabolism in Sedentary, Overweight People.
- ClinicalTrials.gov ID
- NCT01299311
- Acronym / sponsor ID
- MEC 10-2-057
- Conditions
- Overweight
- Keywords
- insulin sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 18 Feb 2011 (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 effect of Non-Exercise Activity Thermogenesis (NEAT) or inactivity on insulin sensitivity and lipid metabolism is unclear. Research recently published shows that activities associated with everyday activities, summarized as NEAT, such as walking and standing, have a much greater role in energy expenditure than exercise. Therefore, the objective of the present study is to evaluate the effect of 4 days of inactivity (mainly sitting), 4 days of everyday activities (sitting, walking and standing), and 4 days of inactivity and exercise (sitting and biking) on glucose metabolism and insulin sensitivity using an oral glucose tolerance test, and on lipid metabolism in sedentary, overweight people. The investigators hypothesize that:
- 4 days of everyday activities (NEAT) will cause an increased glucose tolerance and increased insulin sensitivity compared to 4 days of inactivity in sedentary, overweight people.
- 4 days of exercise will improve glucose tolerance and insulin sensitivity more than 4 days of NEAT with equal energy expenditure, in sedentary, overweight people.
- Fasting triglyceride will have the same course as glucose, mentioned in 1. and 2.
Detailed description
To evaluate the effect of Non-Exercise Activity Thermogenesis (NEAT) on glucose and lipid metabolism in sedentary, overweight people, the subjects included in the study protocol will follow 3 times a certain activity program of 4 days. These activity programs are:
- Inactivity: 14 hours of sitting, 2 hours of everyday activities, 8 hours of sleeping or laying down per day.
- NEAT: 4 hours of walking, 8 hours of sitting, 2 hours of standing, 2 hours of everyday activities, 8 hours of sleeping or laying down per day.
- Exercise: 1 hour biking, 13 hours of sitting, 2 hours of everyday activities, 8 hours of sleeping or laying down per day.
The subjects will be biking using a home trainer, measuring energy expenditure, and supervised by one of the members of the research team. They will bike until they have reached a certain amount of kCal. The subjects will wear two accelerometers during all 3 activity programs to evaluate the amount of each activity (sitting, walking, standing, laying/sleeping). The Computer Science and Applications (CSA) Actigraph accelerometer will be placed on the back and the Continuous Activity Monitor (CAM) Maastricht instrument on the leg. Furthermore, the subjects will be requested to note their activities and dietary intake in a diary. After every 4 days of each activity program, an oral glucose tolerance test will be performed in the morning (fasting state) of the next day (day 5). Before and 15, 30, 45, 60, 90, 120 minutes after ingestion of 75 gram of glucose in water, blood will be drawn for measurements of glucose and insulin. Only at baseline (t=0 minutes), blood will be drawn to measure cholesterol, HDL, LDL, triglycerides, apoA and apoB.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inactivity | No intervention | –4 days of inactivity, mainly sitting |
| NEAT | Active comparator | Behavioral: NEAT4 days of NEAT (everyday activities) |
| Exercise | Active comparator | Behavioral: Exercise4 days of inactivity combined with 1 hour of exercise |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18-30 years old
- BMI between 25.0-30.0 kg/m2
- Sedentary, defined as maximum of exercise of 1 hour/week and less than 2x/week
Key exclusion criteria (7 listed)
- Cardiovascular disease
- Diabetes mellitus type 1 or 2 or fasting glucose > 6.9 mmol/L
- Other diseases that make physical activity difficult
- Alcohol > 2 consumptions/day
- Illegal drug use and cannabis use
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 |
|---|---|---|
| NEAT4 days of everyday activities, including 4 hours of walking, 8 hours of sitting, 2 hours of standing, 2 hours of everyday activities and 8 hours of sleeping or laying down per day | Behavioural | NEAT |
| Exercise4 days of activity program, including 1 hour biking (exercise), 13 hours of sitting, 2 hours of everyday activities and 8 hours of sleeping or laying down per day | Behavioural | Exercise |
Primary outcome
Change in insulin sensitivity after 4 days of NEAT compared to 4 days of inactivity and compared to 4 days of exercise
Time frame: day 5
Change in insulin sensitivity measured using oral glucose tolerance test
1 secondary outcome
Change in fasting triglycerides after 4 days of NEAT compared to 4 days of inactivity and compared to 4 days of exercise
Time frame: 5 day
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 10 Jul 2012.
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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.
Nicolaas C Schaper, Prof., MD principal investigator
Maastricht University Medical Center/ University of Maastricht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEAT and Exercise in people with Overweight, run by Maastricht University Medical Center at 1 site in Netherlands.
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 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 10 Jul 2012. 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 Netherlands. 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?
Change in insulin sensitivity after 4 days of NEAT compared to 4 days of inactivity and compared to 4 days of exercise (time frame: day 5). 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 10 Jul 2012.