- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02581306
Exercise Induced Changes in Fat Metabolism (BC)
March 18, 2022 updated by: Jeffrey F Horowitz, University of Michigan
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age: 18-40
- Body Mass Index: 20-35 kg/m2
- Women must have regularly occurring menses and must be premenopausal
Exclusion Criteria:
- Pregnant or lactating
- Evidence/history of cardiovascular or metabolic disease
- Medications known to affect lipid or glucose metabolism
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Exercise session
All subjects will exercise for 1 hour at a moderate intensity.
There are no different arms in this study
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 day
|
|
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.
|
1 day
|
|
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.
|
1 day
|
|
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.
|
1 day
|
|
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.
|
1 day
|
|
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.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (Actual)
May 11, 2016
Study Completion (Actual)
May 11, 2016
Study Registration Dates
First Submitted
October 13, 2015
First Submitted That Met QC Criteria
October 16, 2015
First Posted (Estimate)
October 20, 2015
Study Record Updates
Last Update Posted (Actual)
March 21, 2022
Last Update Submitted That Met QC Criteria
March 18, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- HUM00103937
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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