Healthy VolunteersBCNCT02581306
Exercise Induced Changes in Fat Metabolism
A study testing Exercise session in people with Healthy Volunteers, run by University of Michigan at 1 site in United States.
Trial summary
If eligible to participate in the research study after completing the physical screening procedures, participants will be asked to return to the Substrate Metabolism Laboratory on another occasion after a short fast (no food or beverages - besides water) for at least 6 hours. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Exercise session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 11 May 2016
- 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
- Age: 18-40
- Body Mass Index: 20-35 kg/m2
- Women must have regularly occurring menses and must be premenopausal
Who cannot join
- Pregnant or lactating
- Evidence/history of cardiovascular or metabolic disease
- Medications known to affect lipid or glucose metabolism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise-mediated Changes in Adipocyte Differentiation and Metabolic Function
If eligible to participate in the research study after completing the physical screening procedures, participants will be asked to return to the Substrate Metabolism Laboratory on another occasion after a short fast (no food or beverages - besides water) for at least 6 hours. After participants arrive, participants will rest quietly for approximately 30 min. The investigators will then collect a blood sample from a vein in participants hand, or forearm. After obtaining a baseline blood sample, participants will exercise at a moderate intensity (on a treadmill or a stationary bike) for one hour. This one hour moderate exercise session will feel like a slow jog during which participants would be able to carry a conversation. In order for the investigators to measure energy expended and the amount of fat participants are burning during exercise, the investigators will periodically ask participants to breathe through a mouthpiece so the investigators can collect participants expired breath. After the exercise session the investigators will collect another blood sample from a vein in participants hand, or forearm.
Read the detailed description
General study design
- Subjects who exercise regularly will be instructed to exercise exactly 3 days before the experimental trial, and then abstain from their exercise training program until after the experiment is complete.
- Subjects will arrive to the Substrate Metabolism Laboratory (1210 CCRB) after at least a 6h fast.
- After resting quietly in the laboratory for approximately 30min, Dr. Horowitz will collect a resting blood sample by venipuncture, as he has done in our other IRB approved protocols (e.g., HUM00029179). Briefly, Dr. Horowitz will wash his hands and put on gloves. The participant's skin will be disinfected at the venipuncture site with isopropyl alcohol. Single-use needles will be used for each participant and immediately discarded into a biohazard sharps container after use. After the blood draw, direct pressure will be applied to the site of needle insertion to avoid/reduce bruising and discomfort.
- Subjects will exercise (bike or treadmill) for 1h at a moderate exercise intensity (approximately 65% of their predicted VO2peak). This moderate exercise intensity has been used extensively by Dr. Horowitz's laboratory in previous exercise testing and training studies in both lean and obese individuals, and is well tolerated by both populations.
- During the exercise session, subjects will wear a heart rate monitor to ensure participants are exercising at the correct exercise intensity.
- Subjects will also use the mouthpiece and nose clip (described above) for ~5min at the beginning, middle, and end of exercise to verify they are exercising at approximately 65% of their predicted VO2peak.
- A study team member will be present with the participant at all times during exercise to ensure the comfort and safety.
- Immediately after exercise another blood sample will be collected.
- Conditions
- Healthy Volunteers
- Being tested
- Exercise session
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise sessionOther
There is no drug or device intervention in this study. Subjects will exercise at a moderate intensity for 60 minutes and a blood sample will be obtained before and after the exercise session
| Study group | Role | What they receive |
|---|---|---|
| Exercise session | Other | All subjects will exercise for 1 hour at a moderate intensity. There are no different arms in this study Receives: Other: Exercise session |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in plasma concentrations of epinephrine after a session of exercise
Plasma levels will be measured using appropriate commercially available assays.
Measured: 1 day
changes in plasma concentrations of lactate after a session of exercise
Plasma levels will be measured using appropriate commercially available assays.
Measured: 1 day
changes in plasma concentrations of fatty acids after a session of exercise
Plasma levels will be measured using appropriate commercially available assays.
Measured: 1 day
changes in plasma concentrations of IL-6 after a session of exercise
Plasma levels will be measured using appropriate commercially available assays.
Measured: 1 day
changes in plasma concentrations of irisin after a session of exercise
Plasma levels will be measured using appropriate commercially available assays.
Measured: 1 day
changes in plasma concentrations of growth hormone after a session of exercise
Plasma levels will be measured using appropriate commercially available assays.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startOct 2015
- Primary completion11 May 2016
- Study completion11 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 29 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02581306
- Sponsor's protocol ID
- HUM00103937
- Acronym
- BC
- Status last verified
- Mar 2022
- First submitted
- 13 Oct 2015
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise-mediated Changes in Adipocyte Differentiation and Metabolic Function
- ClinicalTrials.gov ID
- NCT02581306
- Acronym / sponsor ID
- BC / HUM00103937
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- 11 May 2016 (actual)
- Study completion
- 11 May 2016 (actual)
- First posted
- 20 Oct 2015 (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.
If eligible to participate in the research study after completing the physical screening procedures, participants will be asked to return to the Substrate Metabolism Laboratory on another occasion after a short fast (no food or beverages - besides water) for at least 6 hours. After participants arrive, participants will rest quietly for approximately 30 min. The investigators will then collect a blood sample from a vein in participants hand, or forearm. After obtaining a baseline blood sample, participants will exercise at a moderate intensity (on a treadmill or a stationary bike) for one hour. This one hour moderate exercise session will feel like a slow jog during which participants would be able to carry a conversation. In order for the investigators to measure energy expended and the amount of fat participants are burning during exercise, the investigators will periodically ask participants to breathe through a mouthpiece so the investigators can collect participants expired breath. After the exercise session the investigators will collect another blood sample from a vein in participants hand, or forearm.
Detailed description
General study design
- Subjects who exercise regularly will be instructed to exercise exactly 3 days before the experimental trial, and then abstain from their exercise training program until after the experiment is complete.
- Subjects will arrive to the Substrate Metabolism Laboratory (1210 CCRB) after at least a 6h fast.
- After resting quietly in the laboratory for approximately 30min, Dr. Horowitz will collect a resting blood sample by venipuncture, as he has done in our other IRB approved protocols (e.g., HUM00029179). Briefly, Dr. Horowitz will wash his hands and put on gloves. The participant's skin will be disinfected at the venipuncture site with isopropyl alcohol. Single-use needles will be used for each participant and immediately discarded into a biohazard sharps container after use. After the blood draw, direct pressure will be applied to the site of needle insertion to avoid/reduce bruising and discomfort.
- Subjects will exercise (bike or treadmill) for 1h at a moderate exercise intensity (approximately 65% of their predicted VO2peak). This moderate exercise intensity has been used extensively by Dr. Horowitz's laboratory in previous exercise testing and training studies in both lean and obese individuals, and is well tolerated by both populations.
- During the exercise session, subjects will wear a heart rate monitor to ensure participants are exercising at the correct exercise intensity.
- Subjects will also use the mouthpiece and nose clip (described above) for ~5min at the beginning, middle, and end of exercise to verify they are exercising at approximately 65% of their predicted VO2peak.
- A study team member will be present with the participant at all times during exercise to ensure the comfort and safety.
- Immediately after exercise another blood sample will be collected.
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: Exercise sessionAll subjects will exercise for 1 hour at a moderate intensity. There are no different arms in this study |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: 18-40
- Body Mass Index: 20-35 kg/m2
- 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
- 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 |
|---|---|---|
| Exercise sessionThere is no drug or device intervention in this study. Subjects will exercise at a moderate intensity for 60 minutes and a blood sample will be obtained before and after the exercise session | Other | Exercise session |
Primary outcome
changes in plasma concentrations of epinephrine after a session of exercise
Time frame: 1 day
Plasma levels will be measured using appropriate commercially available assays.
changes in plasma concentrations of lactate after a session of exercise
Time frame: 1 day
Plasma levels will be measured using appropriate commercially available assays.
changes in plasma concentrations of fatty acids after a session of exercise
Time frame: 1 day
Plasma levels will be measured using appropriate commercially available assays.
changes in plasma concentrations of IL-6 after a session of exercise
Time frame: 1 day
Plasma levels will be measured using appropriate commercially available assays.
changes in plasma concentrations of irisin after a session of exercise
Time frame: 1 day
Plasma levels will be measured using appropriate commercially available assays.
changes in plasma concentrations of growth hormone after a session of exercise
Time frame: 1 day
Plasma levels will be measured using appropriate commercially available assays.
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 21 Mar 2022.
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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 Exercise session in people with Healthy Volunteers, 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 3 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 21 Mar 2022. 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?
changes in plasma concentrations of epinephrine after a session of exercise (time frame: 1 day). The study lists 6 primary outcomes in all. 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 21 Mar 2022; AzTrials last refreshed its copy on 2 Nov 2026.