ObesityNCT01452087
Health Benefits of Chronic vs. Acute Exercise in Overweight Adults
A study testing Exercise in people with Obesity, run by University of Michigan at 1 site in United States.
Trial summary
Compare the effects of single session of exercise vs. chronic exercise training on key risk factors associated with Metabolic Syndrome (e.g., glucose tolerance, blood lipid profile, and blood pressure) in overweight adults. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Oct 2014
- 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
- Body Mass Index: 27-34 kg/m2;
- Regular exercisers(≥4 days/wk of aerobic exercise;
- 30-60min/session at moderate and vigorous intensities);
- Non-exercisers (no regularly planned exercise/physical activity);
- Women must have regularly occurring menses and must be premenopausal.
Who cannot join
- Pregnant or lactating;
- Evidence/history of cardiovascular or metabolic disease;
- Currently taking medications known to affect lipid or glucose metabolism.
Trial locations and contacts
1 site in 1 country.
United States1 site
Substrate Metabolism Laboratory
Ann Arbor, Michigan, 48109
About this study
Compare the effects of single session of exercise vs. chronic exercise training on key risk factors associated with Metabolic Syndrome (e.g., glucose tolerance, blood lipid profile, and blood pressure) in overweight adults.
- Conditions
- Obesity
- Being tested
- Exercise
- Keywords
- insulin sensitivity, exercise
- Medical subject headings
- Obesity, Insulin Resistance, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Subjects will exercise on a treadmill for 1 hour at moderate intensity (i.e., 90% of the exercise intensity found to elicit their ventilatory threshold during the preliminary testing, which is equivalent to approximately 60% of their maximal predicted heart rate).
| Study group | Role | What they receive |
|---|---|---|
| Exercise Session | Other | Subjects will exercise on a treadmill for 1 hour at moderate intensity (i.e., 90% of the exercise intensity found to elicit their ventilatory threshold during the preliminary testing, which is equivalent to approximately 60% of their maximal predicted heart rate). Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral glucose tolerance test
Measured: 2 hour
Secondary outcomes (1)
Resting Metabolic Rate
Measured: 20-30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2011 (estimated)
- Study startMay 2009
- Primary completionFeb 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JEFFREY F HOROWITZ, University of Michigan
- Investigators
- Jeffrey F Horowitz, Ph.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452087
- Sponsor's protocol ID
- R01 DK077966 - R
- Other IDs
- R01DK077966
- Status last verified
- Nov 2014
- First submitted
- 11 Oct 2011
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Benefits of Chronic vs. Acute Exercise in Overweight Adults
- ClinicalTrials.gov ID
- NCT01452087
- Acronym / sponsor ID
- R01 DK077966 - R
- Conditions
- Obesity
- Keywords
- insulin sensitivity, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- May 2009
- Primary completion
- Feb 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 14 Oct 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.
Compare the effects of single session of exercise vs. chronic exercise training on key risk factors associated with Metabolic Syndrome (e.g., glucose tolerance, blood lipid profile, and blood pressure) in overweight adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise Session | Other | Other: ExerciseSubjects will exercise on a treadmill for 1 hour at moderate intensity (i.e., 90% of the exercise intensity found to elicit their ventilatory threshold during the preliminary testing, which is equivalent to approximately 60% of their maximal predicted heart rate). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Body Mass Index: 27-34 kg/m2;
- Regular exercisers(≥4 days/wk of aerobic exercise;
- 30-60min/session at moderate and vigorous intensities);
- Non-exercisers (no regularly planned exercise/physical activity);
- Women must have regularly occurring menses and must be premenopausal.
Key exclusion criteria (3 listed)
- Pregnant or lactating;
- Evidence/history of cardiovascular or metabolic disease;
- Currently taking medications known to affect lipid or glucose metabolism.
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 |
|---|---|---|
| ExerciseSubjects will exercise on a treadmill for 1 hour at moderate intensity (i.e., 90% of the exercise intensity found to elicit their ventilatory threshold during the preliminary testing, which is equivalent to approximately 60% of their maximal predicted heart rate). | Other | Exercise Session |
Primary outcome
oral glucose tolerance test
Time frame: 2 hour
1 secondary outcome
Resting Metabolic Rate
Time frame: 20-30 min
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 24 Nov 2014.
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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.
Jeffrey F Horowitz, Ph.D. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Obesity, run by University of Michigan 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 5 inclusion and 3 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 24 Nov 2014. 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?
oral glucose tolerance test (time frame: 2 hour). 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 24 Nov 2014.