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HealthyNCT06053125

A Study of Adipose Tissue in Adaptive Responses to Exercise

A study testing Adipose Tissue Biopsy and Exercise in people with Healthy and Obesity, run by Mayo Clinic at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this research is to determine how exercise affects fat (adipose) tissue and how changes to adipose tissue that occur during and after exercise might improve health in aging and obesity. Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Healthy, Obesity
What is being tested?
Adipose Tissue Biopsy and Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteUnited States
Study dates
9 Nov 2023to Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adults between the ages of 18-35 OR 65-85.
  • BMI 18.5 kg/m2 - 40 kg/m2
  • Weight stable (≥ 3 months)
  • Generally healthy

Who cannot join

  • Participation in ≥ 30 minutes of structured physical activity ≥ 2 days per week.
  • Smoking/tobacco use.
  • Alcohol/substance abuse.
  • Pregnancy and breastfeeding.
  • Anemia.
  • Abnormal renal function.
Show all 13Show fewer
  • Blood clotting disorders.
  • Coronary artery disease.
  • Uncontrolled thyroid disease.
  • Liver disease.
  • Use of medications known to influence the main outcomes of the study.
  • Orthopedic problems that may be aggravated by exercise.
  • Chronic disease at the discretion of the investigators.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: The Role of Adipose Tissue in Adaptive Responses to Exercise

The purpose of this research is to determine how exercise affects fat (adipose) tissue and how changes to adipose tissue that occur during and after exercise might improve health in aging and obesity.

Read the detailed description

Adipose tissue has important endocrine functions that influence metabolic health. Early evidence shows that adipose adapts to physiological stress, including exercise. The objective here is to determine how exercise-induced alterations in adipose tissue cellular composition and endocrine signaling may contribute to the beneficial adaptations to exercise in aging and obesity.

Immune cell populations and inflammatory signatures will be assessed in subcutaneous abdominal adipose tissue biopsies collected from obese and normal weight young and older adults before, immediately after, and 3 hours after a 30-min bout of cycling exercise at 70% of maximal oxygen consumption (VO2max). Mass spectrometry, Olink targeted inflammation assays, and RNA sequencing will be used for full proteomic and transcriptomic characterization of the adipose tissue secretome (the proteins and molecules secreted from the adipose tissue) and the cargo of extracellular vesicles isolated from plasma and media collected from cultured human adipose tissue explants generated from each time point.

Overall, the primary hypothesis of the proposed work is that a single bout of exercise triggers transient changes in adipose tissue paracrine/endocrine signals and immune cellular composition. The investigators propose that these responses contribute to the beneficial effects of exercise locally and in distal tissues and that the cumulative effects of acute changes in adipose tissue likely contribute to the positive alterations in adipose tissue associated with exercise training.

Conditions
Healthy, Obesity
Being tested
Adipose Tissue Biopsy, Exercise
Keywords
exercise, adipose, cytokines
Medical subject headings
Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adipose Tissue BiopsyProcedure or surgery

    Fat sample collected from abdomen before exercise, immediately after exercise, and 3 hours after exercise

  • ExerciseBehavioural

    30 minutes of exercise on a cycle ergometer exercise machine

Study groups in NCT06053125
Study groupRoleWhat they receive
Older adults with obesityExperimentalParticipants with obesity as determined by the principal investigator and aged 65-85 years will have an adipose tissue biopsy taken from the abdomen before and after exercise.
Receives: Procedure: Adipose Tissue Biopsy; Behavioral: Exercise
Older adults without obesityExperimentalParticipants with obesity as determined by the principal investigator and aged 65-85 years will have an adipose tissue biopsy taken from the abdomen before and after exercise.
Receives: Procedure: Adipose Tissue Biopsy; Behavioral: Exercise
Young adults with obesityExperimentalParticipants with obesity as determined by the principal investigator and aged 18-35 years will have an adipose tissue biopsy taken from the abdomen before and after exercise.
Receives: Procedure: Adipose Tissue Biopsy; Behavioral: Exercise
Young adults without obesityExperimentalParticipants with obesity as determined by the principal investigator and aged 18-35 years will have an adipose tissue biopsy taken from the abdomen before and after exercise.
Receives: Procedure: Adipose Tissue Biopsy; Behavioral: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adipose lymphocyte populations

    The numbers of lymphocytes in the adipose tissue will be assessed by flow cytometry.

    Measured: Pre-exercise, immediately post-exercise, and 3 hours after exercise

  2. IL6 secreted from adipose tissue measured using the Olink Target Inflammation Panel (includes 96 inflammation-associated proteins)

    The concentration of 96 IL6 will be measured using the targeted inflammation Olink proximity extension assay panel in media obtained from cultured adipose tissue explants. Adipose tissue samples will be cultured for 3 hours, and the culture media will be removed for the assessment of secreted inflammatory proteins. T

    Measured: Pre-exercise, immediately post-exercise, and 3 hours after exercise

  3. Adipose tissue macrophage populations

    Numbers of macrophages in the adipose tissue will be assessed by immunohistochemistry.

    Measured: Pre-exercise, immediately post-exercise, and 3 hours after exercise

  4. Adipose tissue gene expression of interleukin (IL)-6 measured by polymerase chain reaction (PCR).

    Gene expression of the inflammatory cytokine IL-6 will be measured in adipose tissue samples using real time (RT)-PCR.

    Measured: Pre-exercise, immediately post-exercise, and 3 hours after exercise

  5. Adipose tissue gene expression of interleukin (IL)-8 measured by PCR.

    Gene expression of the inflammatory cytokine IL-8 will be assessed in adipose tissue samples using real-time (RT)-PCR.

    Measured: Pre-exercise, immediately post-exercise, and 3 hours after exercise

  6. Adipose tissue gene expression of cluster of differentiation 68 (CD68) measured by PCR.

    Gene expression of the macrophage marker CD68 be assessed in adipose tissue samples using real time (RT)-PCR.

    Measured: Pre-exercise, immediately post-exercise, and 3 hours after exercise

  7. Adipose tissue gene expression of cluster of differentiation 163 (CD163) measured by PCR.

    Gene expression of the anti-inflammatory macrophage marker CD163 will be assessed in adipose tissue samples using RT-PCR.

    Measured: Pre-exercise, immediately post-exercise, and 3 hours after exercise

  8. Adipose tissue gene expression of cluster of differentiation 206 (CD206) measured by PCR.

    Gene expression of the anti-inflammatory macrophage marker CD206 will be assessed in adipose tissue samples using RT-PCR.

    Measured: Pre-exercise, immediately post-exercise, and 3 hours after exercise

  9. Adipose tissue gene expression of adhesion G-protein coupled receptor E (ADGRE) measured by PCR.

    Gene expression of the macrophage marker ADGRE will be assessed in adipose tissue samples using RT-PCR.

    Measured: Pre-exercise, immediately post-exercise, and 3 hours after exercise

  10. Adipose tissue gene expression of inducible nitric oxide synthase (INOS) measured by PCR.

    Gene expression of the pro-inflammatory macrophage marker INOS will be assessed in adipose tissue samples using RT-PCR.

    Measured: Pre-exercise, immediately post-exercise, and 3 hours after exercise

  11. Adipose tissue gene expression of monocyte chemoattractant protein-1 (MCP1) measured by PCR.

    Gene expression of the inflammatory cytokine MCP1 will be assessed in adipose tissue samples using RT-PCR.

    Measured: Pre-exercise, immediately post-exercise, and 3 hours after exercise

  12. Adipose tissue gene expression of tumor necrosis factor alpha (TNFa) measured by PCR.

    Gene expression of the inflammatory cytokine TNFa will be assessed in adipose tissue samples using RT-PCR.

    Measured: Pre-exercise, immediately post-exercise, and 3 hours after exercise

  13. Adipose tissue gene expression of leptin (LEPD) measured by PCR.

    Gene expression of the pro-inflammatory adipokine LEPD will be assessed in adipose tissue samples using RT-PCR.

    Measured: Pre-exercise, immediately post-exercise, and 3 hours after exercise

  14. Adipose tissue gene expression of adiponectin (ADIPOQ) measured by PCR.

    Gene expression of the anti-inflammatory adipokine ADIPOQ will be assessed in adipose tissue samples using RT-PCR.

    Measured: Pre-exercise, immediately post-exercise, and 3 hours after exercise

  15. Inflammatory proteins found in adipose tissue measured using the Olink Target Inflammation Panel (includes 96 inflammation-associated proteins)

    The concentrations of 96 different inflammatory proteins (including various cytokines and adipokines) will be measured in adipose tissue lysates using the targeted inflammation Olink proximity extension assay panel. This assay measures all 96 proteins in a single assay and all are reported as normalized protein expression values.

    Measured: Pre-exercise, immediately post-exercise, and 3 hours after exercise

  16. Protein cargo of adipose extracellular vesicles measured using mass spectrometry

    Adipose tissue samples will be cultured for 3 hours, and the culture media will be removed. From this media, extracellular vesicles will be isolated. In these extracellular vesicles, mass spectrometry will be performed to examine the entire proteome (all proteins) contained within these extracellular vesicles. Using the large number of proteins identified, the investigators will examine changes in categories of protein types (e.g., inflammatory proteins, metabolic proteins, transcriptional proteins).

    Measured: Pre-exercise, immediately post-exercise, and 3 hours after exercise

Secondary outcomes (3)
  1. Adipocyte cell size

    Adipocyte cell size will be determined using methylene blue staining and microscopy.

    Measured: Pre-exercise, immediately post-exercise, and 3 hours after exercise

  2. Plasma IL6 concentrations measured using the Olink Target Inflammation Panel

    The concentration of IL6 will be measured in plasma samples using the targeted inflammation Olink proximity extension assay panel. This assay measures 96 proteins in a single assay and all are reported as normalized protein expression values.

    Measured: Pre-exercise, immediately post-exercise, and 3 hours after exercise

  3. Protein cargo of plasma extracellular vesicles measured using mass spectrometry extracellular vesicles

    Extracellular vesicles will be isolated from plasma samples. In these extracellular vesicles, mass spectrometry will be performed to examine the entire proteome (all proteins) contained within these extracellular vesicles. Using the large number of proteins identified, the investigators will examine changes in categories of protein types (e.g., inflammatory proteins, metabolic proteins, transcriptional proteins).

    Measured: Pre-exercise, immediately post-exercise, and 3 hours after exercise

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2023
  2. Study start9 Nov 2023
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06053125
Sponsor's protocol ID
23-002049
Other IDs
K01DK134765
Status last verified
May 2026
First submitted
7 Sep 2023
Last updated
6 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Adipose Tissue Biopsy and Exercise in people with Healthy and Obesity, run by Mayo Clinic 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 13 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: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. 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?

This study is still under way. Results are not available in the source record yet.

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?

Adipose lymphocyte populations (time frame: Pre-exercise, immediately post-exercise, and 3 hours after exercise). The study lists 16 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 6 May 2026.

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