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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Exercise session
All subjects will exercise for 1 hour at a moderate intensity. There are no different arms in this study
Other: Exercise session
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Michigan

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 11, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 11, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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