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Recruiting

NCT Number: NCT05857150

Exercise Response in Humans With Obesity

This study is being done to understand how chronic inflammation affects muscle function and responses to exercise.

Recruiting

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Key information

Conditions

Obese Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Rachel Passehl

CONTACT

[email protected]

507-255-8112

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Treadmill Test

Diagnostic 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).

Strength Test

Diagnostic Test

Measure the strength of leg muscles by kicking against a machine with resistance.

Dual-energy X-ray absorptiometry

Diagnostic Test

Body composition measurement.

Other names: DEXA

Muscle biopsy

Procedure

Obtain a small piece of muscles from the upper part of the legs

Fat Biopsy

Procedure

Fat sample taken from abdomen

Resting Energy Expenditure

Diagnostic Test

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

Magnetic Resonance Imaging

Diagnostic Test

MRI on upper leg to look at fat and muscle

Other names: MRI

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Rachel Passehl

CONTACT

[email protected]

507-255-8112

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
May 12, 2023
Registry last updated
Aug 29, 2025

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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