Metabolic DiseaseFLOWNCT03314506
Adipose Tissue Cellular Response to Exercise in Healthy Humans
A study testing Exercise in people with Metabolic Disease and Adipose Tissue, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to measure the effects of a single session of exercise on changes in the cellular composition of the body fat of humans. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disease, Adipose Tissue
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 8 Aug 2019
- 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: 20-27 kg/m2
- Regular exercise (less than or equal to 3 days/week of aerobic exercise; 30-60 minutes/session at moderate and vigorous intensities)
- Women must have regularly occurring menses and must be premenopausal
Who cannot join
- Blood pressure greater than 140/90 mm Hg
- Pregnant or lactating
- Evidence/history of cardiovascular or metabolic disease
- Medications known to affect lipid or glucose metabolism, or inflammation
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to measure the effects of a single session of exercise on changes in the cellular composition of the body fat of humans.
Read the detailed description
Fat tissue is far more than just a place where humans store body fat. Fat tissue contains many different types of cells, such as immune cells, endothelial cells, and fat precursor cells. Differences or changes in the number of immune cells, endothelial cells, and fat precursor cells in fat tissue can have a great impact on metabolic health. The abundance of all immune cells, endothelial cells, and fat precursor cell types are known to change when a person loses or gains weight. For example, the abundance of inflammatory cells is often found to decrease markedly with weight loss - and this change has been linked to the profound improvements in metabolic health that occur with weight loss. In contrast, the effects of exercise on immune cells, endothelial cells, and fat precursor cells in fat tissue is not known. Determining the effects of exercise on changes in the cellular composition within fat tissue will provide important information for optimizing lifestyle interventions aimed at improving metabolic health.
- Conditions
- Metabolic Disease, Adipose Tissue
- Being tested
- Exercise
- Keywords
- exercise
- Medical subject headings
- Metabolic Diseases, 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 a moderate intensity (approximately 70% of their predicted VO2peak).
| Study group | Role | What they receive |
|---|---|---|
| Trial | Experimental | Subjects will need to come to the Substrate Metabolism Laboratory in the morning around 7:00 AM. After about a 15-30 minute rest, the study team will collect a blood sample from the subject's hand or forearm. The study team will also obtain a small sample of fat tissue from the area just underneath the skin near the belly button. Next, subjects will exercise on a treadmill at a moderate intensity for about 1 hour. Immediately after exercising the study team will collect a blood sample. The subject will remain resting in the laboratory for 3 hours after exercise, and then the study team will collect another blood and fat tissue sample. Upon completion, the subject will be provided a snack before leaving the laboratory. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantifying the change in markers of macrophage abundance in adipose tissue
The stromovascular fraction will be isolated from subcutaneous lipo-aspirate samples by collagenase digestion and a series of filtration/wash steps (routinely performed by our lab). This isolation protocol has been optimized to yield the minimum number of stromal cells required to identify and recover the following cell populations by fluorescence-activated cell sorting (FACS), listed as cell surface stain = cell type: CD64+/CD11c+ = macrophages
FACS will be performed at the University of Michigan Flow Cytometry Core, and sorted cells will be recovered for subsequent gene expression analysis using the StepOnePlus real time PCR system (Life Technologies) with fluorescent probe-based assays.
Measured: 1 day
Secondary outcomes (1)
Quantifying the change in markers of endothelial cell and pre-adipocytes in adipose tissue
The stromovascular fraction will be isolated from subcutaneous lipo-aspirate samples by collagenase digestion and a series of filtration/wash steps (routinely performed by our lab). This isolation protocol has been optimized to yield the minimum number of stromal cells required to identify and recover the following cell populations by fluorescence-activated cell sorting (FACS), listed as cell surface stain = cell type: CD34+/CD31+ = endothelial cells
FACS will be performed at the University of Michigan Flow Cytometry Core, and sorted cells will be recovered for subsequent gene expression analysis using the StepOnePlus real time PCR system (Life Technologies) with fluorescent probe-based 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 posted19 Oct 2017
- Study start1 Nov 2017
- Primary completion8 Aug 2019
- Study completion8 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DiseaseStudies 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
- 40 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, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314506
- Sponsor's protocol ID
- HUM00131070
- Acronym
- FLOW
- Status last verified
- Mar 2022
- First submitted
- 27 Sep 2017
- Last updated
- 21 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- Adipose Tissue Cellular Response to Exercise in Healthy Humans
- ClinicalTrials.gov ID
- NCT03314506
- Acronym / sponsor ID
- FLOW / HUM00131070
- Conditions
- Metabolic Disease, Adipose Tissue
- Keywords
- exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 8 Aug 2019 (actual)
- Study completion
- 8 Aug 2019 (actual)
- First posted
- 19 Oct 2017 (actual)
- 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.
The purpose of this study is to measure the effects of a single session of exercise on changes in the cellular composition of the body fat of humans.
Detailed description
Fat tissue is far more than just a place where humans store body fat. Fat tissue contains many different types of cells, such as immune cells, endothelial cells, and fat precursor cells. Differences or changes in the number of immune cells, endothelial cells, and fat precursor cells in fat tissue can have a great impact on metabolic health. The abundance of all immune cells, endothelial cells, and fat precursor cell types are known to change when a person loses or gains weight. For example, the abundance of inflammatory cells is often found to decrease markedly with weight loss - and this change has been linked to the profound improvements in metabolic health that occur with weight loss. In contrast, the effects of exercise on immune cells, endothelial cells, and fat precursor cells in fat tissue is not known. Determining the effects of exercise on changes in the cellular composition within fat tissue will provide important information for optimizing lifestyle interventions aimed at improving metabolic health.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trial | Experimental | Other: ExerciseSubjects will need to come to the Substrate Metabolism Laboratory in the morning around 7:00 AM. After about a 15-30 minute rest, the study team will collect a blood sample from the subject's hand or forearm. The study team will also obtain a small sample of fat tissue from the area just underneath the skin near the belly button. Next, subjects will exercise on a treadmill at a moderate intensity for about 1 hour. Immediately after exercising the study team will collect a blood sample. The subject will remain resting in the laboratory for 3 hours after exercise, and then the study team will collect another blood and fat tissue sample. Upon completion, the subject will be provided a snack before leaving the laboratory. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 18-40
- Body Mass Index: 20-27 kg/m2
- Regular exercise (less than or equal to 3 days/week of aerobic exercise; 30-60 minutes/session at moderate and vigorous intensities)
- Women must have regularly occurring menses and must be premenopausal
Key exclusion criteria (4 listed)
- Blood pressure greater than 140/90 mm Hg
- Pregnant or lactating
- Evidence/history of cardiovascular or metabolic disease
- Medications known to affect lipid or glucose metabolism, or inflammation
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 a moderate intensity (approximately 70% of their predicted VO2peak). | Other | Trial |
Primary outcome
Quantifying the change in markers of macrophage abundance in adipose tissue
Time frame: 1 day
The stromovascular fraction will be isolated from subcutaneous lipo-aspirate samples by collagenase digestion and a series of filtration/wash steps (routinely performed by our lab). This isolation protocol has been optimized to yield the minimum number of stromal cells required to identify and recover the following cell populations by fluorescence-activated cell sorting (FACS), listed as cell surface stain = cell type: CD64+/CD11c+ = macrophages FACS will be performed at the University of Michigan Flow Cytometry Core, and sorted cells will be recovered for subsequent gene expression analysis using the StepOnePlus real time PCR system (Life Technologies) with fluorescent probe-based assays.
1 secondary outcome
Quantifying the change in markers of endothelial cell and pre-adipocytes in adipose tissue
Time frame: 1 day
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.
Jeffrey F Horowitz 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 Metabolic Disease and Adipose Tissue, 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 4 inclusion and 4 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?
Quantifying the change in markers of macrophage abundance in adipose tissue (time frame: 1 day). 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.