InactivityNCT01828229
Consequences of Human Inactivity
A study testing female inactivity and hypercaloric diet, inactivity and inactivity and hypercaloric diet in people with Inactivity and Obesity, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Epidemiological studies as well as both longitudinal animal and human inactivity studies indicate that low physical activity is associated with the pathophysiology of type 2 diabetes mellitus (T2DM) and obesity, and recently it has been estimated that physical inactivity (worldwide) causes 7% of the burden of disease… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Inactivity, Obesity, Type 2 Diabetes
- What is being tested?
- female inactivity and hypercaloric diet, inactivity and inactivity and hypercaloric diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2009to Jun 2015
- 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
- Normal physical active
- Healthy
- 18-40 y of age
- Non-smokers
Who cannot join
- Pregnancy
- Diabetes in family
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center og inflammation and metabolism, Rigshospitalet
Copenhagen
About this study
Epidemiological studies as well as both longitudinal animal and human inactivity studies indicate that low physical activity is associated with the pathophysiology of type 2 diabetes mellitus (T2DM) and obesity, and recently it has been estimated that physical inactivity (worldwide) causes 7% of the burden of disease related to e.g. T2DM. Physical inactivity, a high energy dietary intake, and T2DM are also associated with dementia, depression, and impaired cognitive function. It is critical that we understand how inactivity alters body composition, glucose and lipid metabolism, and cognitive function, if normal physical activity can prevent these changes, and if there are any differences between sexes.
The present protocol is divided in several in several sub-studies:
- To test whether and how a physically inactive lifestyle will influence body composition, glucose and lipid metabolism, and cognitive function.
- To test whether normal physical activity can prevent the deleterious effect of a physically inactive lifestyle despite a high-caloric intake.
- To test whether the influence of a physically inactive lifestyle combined with a high-caloric intake differs between sexes.
- Conditions
- Inactivity, Obesity, Type 2 Diabetes
- Being tested
- female inactivity and hypercaloric diet, inactivity, inactivity and hypercaloric diet, normal activity and hypercaloric diet, inactivity and iso-caloric diet
- Keywords
- Inactivity, Obesity, Type 2 diabetes, glucose metabolism, Lipid metabolism, Cognitive function
- Medical subject headings
- Sedentary Behavior, Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
female inactivity and hypercaloric dietBehavioural
female inactivity and hypercaloric diet for 2 weeks
inactivityBehavioural
inactivity for 2 weeks
inactivity and hypercaloric dietBehavioural
inactivity and hypercaloric diet for 2 weeks
normal activity and hypercaloric dietBehavioural
normal activity and hypercaloric diet for 2 weeks
inactivity and iso-caloric dietBehavioural
inactivity and iso-caloric diet for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| female inactivity and hypercaloric diet | Experimental | inactivity and hypercaloric diet in women for two weeks Receives: Behavioral: female inactivity and hypercaloric diet |
| inactivity | Experimental | Inactivity for two weeks Receives: Behavioral: inactivity |
| inactivity and hypercaloric diet | Experimental | inactivity and hypercaloric diet for two weeks Receives: Behavioral: inactivity and hypercaloric diet |
| normal activity and hypercaloric diet | Experimental | Normal activity and hypercaloric diet for two weeks Receives: Behavioral: normal activity and hypercaloric diet |
| inactivity and iso-caloric diet | Active comparator | inactivity and iso-caloric diet for two weeks Receives: Behavioral: inactivity and iso-caloric diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Area under the curve of plasma glucose and insulin levels during an oral glucose tolerance test
Measured: 2 weeks
Secondary outcomes (1)
visceral adiposity
Amount of visceral fat is determined by MRI scans
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2013 (estimated)
- Study startJan 2009
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InactivityStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Rasmussen Rinnov, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828229
- Sponsor's protocol ID
- H-4-2009-082
- Status last verified
- Jun 2015
- First submitted
- 5 Apr 2013
- Last updated
- 18 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Olsen RH, Krogh-Madsen R, Thomsen C, Booth FW, Pedersen BK. Metabolic responses to reduced daily steps in healthy nonexercising men. JAMA. 2008 Mar 19;299(11):1261-3. doi: 10.1001/jama.299.11.1259. No abstract available.
PubMed 18349087Krogh-Madsen R, Thyfault JP, Broholm C, Mortensen OH, Olsen RH, Mounier R, Plomgaard P, van Hall G, Booth FW, Pedersen BK. A 2-wk reduction of ambulatory activity attenuates peripheral insulin sensitivity. J Appl Physiol (1985). 2010 May;108(5):1034-40. doi: 10.1152/japplphysiol.00977.2009. Epub 2009 Dec 31.
PubMed 20044474Knudsen SH, Hansen LS, Pedersen M, Dejgaard T, Hansen J, Hall GV, Thomsen C, Solomon TP, Pedersen BK, Krogh-Madsen R. Changes in insulin sensitivity precede changes in body composition during 14 days of step reduction combined with overfeeding in healthy young men. J Appl Physiol (1985). 2012 Jul;113(1):7-15. doi: 10.1152/japplphysiol.00189.2011. Epub 2012 May 3.
PubMed 22556394
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consequences of Human Inactivity
- ClinicalTrials.gov ID
- NCT01828229
- Acronym / sponsor ID
- H-4-2009-082
- Conditions
- Inactivity, Obesity, Type 2 Diabetes
- Keywords
- Inactivity, Obesity, Type 2 diabetes, glucose metabolism, Lipid metabolism, Cognitive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 10 Apr 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.
Epidemiological studies as well as both longitudinal animal and human inactivity studies indicate that low physical activity is associated with the pathophysiology of type 2 diabetes mellitus (T2DM) and obesity, and recently it has been estimated that physical inactivity (worldwide) causes 7% of the burden of disease related to e.g. T2DM. Physical inactivity, a high energy dietary intake, and T2DM are also associated with dementia, depression, and impaired cognitive function. It is critical that we understand how inactivity alters body composition, glucose and lipid metabolism, and cognitive function, if normal physical activity can prevent these changes, and if there are any differences between sexes.
The present protocol is divided in several in several sub-studies:
- To test whether and how a physically inactive lifestyle will influence body composition, glucose and lipid metabolism, and cognitive function.
- To test whether normal physical activity can prevent the deleterious effect of a physically inactive lifestyle despite a high-caloric intake.
- To test whether the influence of a physically inactive lifestyle combined with a high-caloric intake differs between sexes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| female inactivity and hypercaloric diet | Experimental | Behavioral: female inactivity and hypercaloric dietinactivity and hypercaloric diet in women for two weeks |
| inactivity | Experimental | Behavioral: inactivityInactivity for two weeks |
| inactivity and hypercaloric diet | Experimental | Behavioral: inactivity and hypercaloric dietinactivity and hypercaloric diet for two weeks |
| normal activity and hypercaloric diet | Experimental | Behavioral: normal activity and hypercaloric dietNormal activity and hypercaloric diet for two weeks |
| inactivity and iso-caloric diet | Active comparator | Behavioral: inactivity and iso-caloric dietinactivity and iso-caloric diet for two weeks |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Normal physical active
- Healthy
- 18-40 y of age
- Non-smokers
Key exclusion criteria (2 listed)
- Pregnancy
- Diabetes in family
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 |
|---|---|---|
| female inactivity and hypercaloric dietfemale inactivity and hypercaloric diet for 2 weeks | Behavioural | female inactivity and hypercaloric diet |
| inactivityinactivity for 2 weeks | Behavioural | inactivity |
| inactivity and hypercaloric dietinactivity and hypercaloric diet for 2 weeks | Behavioural | inactivity and hypercaloric diet |
| normal activity and hypercaloric dietnormal activity and hypercaloric diet for 2 weeks | Behavioural | normal activity and hypercaloric diet |
| inactivity and iso-caloric dietinactivity and iso-caloric diet for 2 weeks | Behavioural | inactivity and iso-caloric diet |
Primary outcome
Insulin sensitivity
Time frame: 2 weeks
Area under the curve of plasma glucose and insulin levels during an oral glucose tolerance test
1 secondary outcome
visceral adiposity
Time frame: 2 weeks
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 18 Jun 2015.
- Background: PubMed 18349087Olsen RH, Krogh-Madsen R, Thomsen C, Booth FW, Pedersen BK. Metabolic responses to reduced daily steps in healthy nonexercising men. JAMA. 2008 Mar 19;299(11):1261-3. doi: 10.1001/jama.299.11.1259. No abstract available.
- Results publication: PubMed 20044474Krogh-Madsen R, Thyfault JP, Broholm C, Mortensen OH, Olsen RH, Mounier R, Plomgaard P, van Hall G, Booth FW, Pedersen BK. A 2-wk reduction of ambulatory activity attenuates peripheral insulin sensitivity. J Appl Physiol (1985). 2010 May;108(5):1034-40. doi: 10.1152/japplphysiol.00977.2009. Epub 2009 Dec 31.
- Results publication: PubMed 22556394Knudsen SH, Hansen LS, Pedersen M, Dejgaard T, Hansen J, Hall GV, Thomsen C, Solomon TP, Pedersen BK, Krogh-Madsen R. Changes in insulin sensitivity precede changes in body composition during 14 days of step reduction combined with overfeeding in healthy young men. J Appl Physiol (1985). 2012 Jul;113(1):7-15. doi: 10.1152/japplphysiol.00189.2011. Epub 2012 May 3.
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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 female inactivity and hypercaloric diet, inactivity and inactivity and hypercaloric diet in people with Inactivity and Obesity, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 4 inclusion and 2 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 18 Jun 2015. 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 Denmark. 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?
Insulin sensitivity (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01828229, which also lists 3 linked publications.
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 18 Jun 2015.