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NCT Number: NCT06053125

A Study 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Healthy Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Adipose tissue biopsy

Procedure

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

Exercise

Behavioral

30 minutes of exercise on a cycle ergometer exercise machine

Primary outcomes

  1. Adipose lymphocyte populations

    Time frame: Pre-exercise, immediately post-exercise, and 3 hours after exercise

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

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

    Time frame: Pre-exercise, immediately post-exercise, and 3 hours after exercise

    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

  3. Adipose tissue macrophage populations

    Time frame: Pre-exercise, immediately post-exercise, and 3 hours after exercise

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

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

    Time frame: Pre-exercise, immediately post-exercise, and 3 hours after exercise

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

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

    Time frame: Pre-exercise, immediately post-exercise, and 3 hours after exercise

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

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

    Time frame: Pre-exercise, immediately post-exercise, and 3 hours after exercise

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

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

    Time frame: Pre-exercise, immediately post-exercise, and 3 hours after exercise

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

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

    Time frame: Pre-exercise, immediately post-exercise, and 3 hours after exercise

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

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

    Time frame: Pre-exercise, immediately post-exercise, and 3 hours after exercise

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

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

    Time frame: Pre-exercise, immediately post-exercise, and 3 hours after exercise

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

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

    Time frame: Pre-exercise, immediately post-exercise, and 3 hours after exercise

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

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

    Time frame: Pre-exercise, immediately post-exercise, and 3 hours after exercise

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

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

    Time frame: Pre-exercise, immediately post-exercise, and 3 hours after exercise

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

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

    Time frame: Pre-exercise, immediately post-exercise, and 3 hours after exercise

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

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

    Time frame: Pre-exercise, immediately post-exercise, and 3 hours after exercise

    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.

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

    Time frame: Pre-exercise, immediately post-exercise, and 3 hours after exercise

    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).

Secondary outcomes

  1. Adipocyte cell size

    Time frame: Pre-exercise, immediately post-exercise, and 3 hours after exercise

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

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

    Time frame: Pre-exercise, immediately post-exercise, and 3 hours after exercise

    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.

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

    Time frame: Pre-exercise, immediately post-exercise, and 3 hours after exercise

    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).

Other outcomes

  1. Body fat percentage

    Time frame: Baseline

    Body fat percentage will be assessed using dual energy x-ray absorptiometry (DEXA).

  2. Cardiorespiratory Fitness

    Time frame: Baseline

    Individual maximal oxygen consumption (VO2 max) will be assessed by indirect calorimetry during a graded exercise test

  3. White blood count

    Time frame: Baseline

    White blood count with differential will be measured by the Mayo clinical lab.

  4. Fasting plasma insulin

    Time frame: Baseline

    Plasma insulin will be measured by the Mayo Clinical Lab.

  5. Fasting plasma glucose

    Time frame: Baseline

    Plasma glucose will be measured by the Mayo Clinical Lab.

  6. Hemoglobin A1c (HbA1c)

    Time frame: Baseline

    HbA1c will be measured by the Mayo Clinical Lab.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

The Role of Adipose Tissue in Adaptive Responses to Exercise

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2023
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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