Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT05857150

Conditions

Obese

Eligibility Criteria

Sex: All

Age: 20 - 45

Healthy Volunteers: Not accepted

Interventions

Treadmill Test

Strength Test

Dual-Energy X-Ray Absorptiometry

Muscle Biopsy

Fat Biopsy

Study Details

Brief summary:

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

Conditions

Obese

Study ID

NCT05857150

Start date

Sep 22, 2023

Status verified date

Aug, 2025

Completion date

Jul, 2029

Anticipated

Primary completion date

Jul, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 45

Healthy Volunteers: Not accepted

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 Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

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).

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).

Interventions

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).

Strength Test

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

Dual-Energy X-Ray Absorptiometry

Body composition measurement.

Muscle Biopsy

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

Fat Biopsy

Fat sample taken from abdomen

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.

Magnetic resonance imaging

MRI on upper leg to look at fat and muscle

Primary outcome measure

  • Change in muscle protein synthesis [ Time Frame: Baseline, post-exercise approximately 8 hours ]

Central Contacts and Locations

Central contacts

Rachel Passehl

507-255-8112Passehl.Rachel@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Rachel Passehl

507-255-8112Passehl.Rachel@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 29, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2025-08-29.