Exercise Response in Humans With Obesity

August 22, 2025 updated by: Ian R. Lanza, Mayo Clinic
This study is being done to understand how chronic inflammation affects muscle function and responses to exercise.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Men and women ages 20-45 years with Body Mass Index less than 25 or greater than 30 kg/m2.

Description

Inclusion Criteria:

  • Obese men and women ≥ 20 and ≤ 45 years of age.

Exclusion Criteria:

  • Diabetes or fasting plasma glucose >126 mg/dL
  • Anemia (female subjects hemoglobin of <11 g/dl and male subjects hemoglobin <12 g/dl)
  • Active coronary artery disease or history of unstable macrovascular disease (unstable angina, myocardial infarction, stroke, and revascularization of coronary, peripheral or carotid artery within 3 months of recruitment)
  • Renal failure (serum creatinine > 1.5mg/dl)
  • Chronic active liver disease defined as aspartate aminotransferase (AST)>144 IU/L or alanine transaminase (ALT) >165 IU/L)
  • Oral warfarin group medications or history of blood clotting disorders.
  • Smoking
  • Pregnancy or breastfeeding
  • Alcohol consumption greater than 2 glasses/day or other substance abuse
  • Untreated or uncontrolled hypothyroidism
  • Debilitating chronic disease (at the discretion of the investigators)

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lean Group
Participants with body mass index 20-25 kg/m^2 will complete an outpatient study visit (body composition, blood draw, treadmill test, strength test) and an inpatient visit (muscle biopsies, fat biopsies, indirect calorimetry, exercise test).
Diagnostic test: Treadmill Test
Measurement of whole-body fitness level. Walking or running on a treadmill and breathing into a machine that measures oxygen level during test. Heart rhythm is continuously monitored during exercise using an electrocardiogram (ECG).
Diagnostic test: Strength Test
Measure the strength of leg muscles by kicking against a machine with resistance.
Diagnostic test: Dual-Energy X-Ray Absorptiometry
Body composition measurement.
Other Names:
  • DEXA
Procedure: Muscle Biopsy
Obtain a small piece of muscles from the upper part of the legs
Procedure: Fat Biopsy
Fat sample taken from abdomen
Diagnostic test: Resting Energy Expenditure
Measured by indirect calorimetry. Measures how much energy the body uses at rest by placing a special plastic dome over the head while resting quietly for 30 minutes. Measures oxygen breathed in and carbon dioxide breathed out.
Other Names:
  • REE
Diagnostic test: Magnetic resonance imaging
MRI on upper leg to look at fat and muscle
Other Names:
  • MRI
Obese Group
Participants with body mass index 30-45 kg/m^2 will complete an outpatient study visit (body composition, blood draw, treadmill test, strength test) and an inpatient visit (muscle biopsies, fat biopsies, indirect calorimetry, exercise test).
Diagnostic test: Treadmill Test
Measurement of whole-body fitness level. Walking or running on a treadmill and breathing into a machine that measures oxygen level during test. Heart rhythm is continuously monitored during exercise using an electrocardiogram (ECG).
Diagnostic test: Strength Test
Measure the strength of leg muscles by kicking against a machine with resistance.
Diagnostic test: Dual-Energy X-Ray Absorptiometry
Body composition measurement.
Other Names:
  • DEXA
Procedure: Muscle Biopsy
Obtain a small piece of muscles from the upper part of the legs
Procedure: Fat Biopsy
Fat sample taken from abdomen
Diagnostic test: Resting Energy Expenditure
Measured by indirect calorimetry. Measures how much energy the body uses at rest by placing a special plastic dome over the head while resting quietly for 30 minutes. Measures oxygen breathed in and carbon dioxide breathed out.
Other Names:
  • REE
Diagnostic test: Magnetic resonance imaging
MRI on upper leg to look at fat and muscle
Other Names:
  • MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in muscle protein synthesis
Time Frame: Baseline, post-exercise approximately 8 hours
Skeletal muscle protein synthesis will be measured from the rate of incorporation of infused amino acids measured by mass spectrometry.
Baseline, post-exercise approximately 8 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mRNA expression of exercise responsive genes
Time Frame: Baseline, post-exercise approximately 8 hours
Measure messenger ribonucleic acids (mRNAs) expression on exercise responsive genes
Baseline, post-exercise approximately 8 hours
Change in expression and activation (phosphorylation) of signaling proteins
Time Frame: Baseline, post-exercise approximately 8 hours
Phosphorylation is a common mechanism for the regulation of receptor function
Baseline, post-exercise approximately 8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Ian Lanza, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Actual)

September 22, 2023

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

July 1, 2029

Study Registration Dates

First Submitted

May 4, 2023

First Submitted That Met QC Criteria

May 4, 2023

First Posted (Actual)

May 12, 2023

Study Record Updates

Last Update Posted (Estimated)

August 29, 2025

Last Update Submitted That Met QC Criteria

August 22, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-012396

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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