ClinicalTrials.gg
CompletedNCT03314506FLOWUpdated Mar 21, 2022

Adipose Tissue Cellular Response to Exercise in Healthy Humans

An interventional study of Exercise in Metabolic Disease and Adipose Tissue, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-21.

Sponsored by University of Michigan · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 272 studies in Metabolic Diseases with a site in United States — 68 open to participants now, 92 under way, 12 of them phase 3. Metabolic Diseases · United States.

Enrollment
116th of 209
40 · median 50
Started
2017
with 8 others
No phase
88 of 272
25 open now
Registered
125th of 272
by date
Lead sponsor
6 of 272
University of Michigan

Among the 272 studies in Metabolic Diseases with a site in United States, this one is the 116th largest by enrollment of the 209 interventional ones that give a count, is one of 9 that started in 2017, is one of 88 with no phase, and was the 125th registered.

Metabolic Diseases

763 studies on the registry are indexed under Metabolic Diseases; 192 are open to participants now.

Browse Metabolic Diseases studies →

Open to participants now

68 of the 272 studies in Metabolic Diseases with a site in United States are open now. Recruiting first, the newest first:

63 more — sign in →

All 68 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 133 Metabolic Diseases studies recruiting now, 47 (35%) set no upper age limit and 63 (47%) stop at 75 or younger; 38 take children under 18; 50 take healthy volunteers.

This study: 18 Years to 40 Years · all sexes · healthy volunteers too.

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02

Study 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 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.

03

Conditions studied

  • Metabolic Disease
  • Adipose Tissue

Keywords

  • exercise
04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age: 18-40
  • : 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

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Trial

    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.

    Other: Exercise

Interventions

  • OtherExercise

    Subjects will exercise on a treadmill for 1 hour at a moderate intensity (approximately 70% of their predicted VO2peak).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: 1 day

07

Study locations

1 site
  • University of Michigan
    Ann Arbor, Michigan 48109, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2017 to primary completion in Aug 2019, 21 months.

Of 182 non-industry interventional studies with no phase under Metabolic Diseases, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 44. This study's 21 months is close to that.

Counting every sponsor, half of 201 studies reached it within 22 months; a quarter within 10 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 27, 2017
First posted
Oct 19, 2017
StartActual
Nov 1, 2017
Primary completionActual
Aug 8, 2019
CompletionActual
Aug 8, 2019
Last update
Mar 21, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03314506
Responsible party
Jeffrey F Horowitz (Associate Professor, Movement Science, School of Kinesiology, University of Michigan) — Principal investigator
First posted
Oct 19, 2017
Start date
Nov 1, 2017
Primary completion
Aug 8, 2019
Completion
Aug 8, 2019
Last update
Mar 21, 2022

Study contacts

Jeffrey F Horowitz
principal investigator · University of Michigan

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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