Exercise Response in Humans With Obesity

NCT05857150 | Recruiting

• 1 other identifier: 22-012396
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obese

Outcome Measures

Primary Outcomes (1)

• Change in muscle protein synthesis

  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 Outcomes (2)

• Change in mRNA expression of exercise responsive genes

  Baseline, post-exercise approximately 8 hours

• Change in expression and activation (phosphorylation) of signaling proteins

  Baseline, post-exercise approximately 8 hours

Study Arms (2)

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; Diagnostic Test: Strength Test; Diagnostic Test: Dual-Energy X-Ray Absorptiometry; Procedure: Muscle Biopsy; Procedure: Fat Biopsy; Diagnostic Test: Resting Energy Expenditure; Diagnostic Test: Magnetic resonance imaging

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; Diagnostic Test: Strength Test; Diagnostic Test: Dual-Energy X-Ray Absorptiometry; Procedure: Muscle Biopsy; Procedure: Fat Biopsy; Diagnostic Test: Resting Energy Expenditure; Diagnostic Test: Magnetic resonance imaging

Interventions

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).

Lean Group; Obese Group

Strength Test DIAGNOSTIC_TEST

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

Lean Group; Obese Group

Dual-Energy X-Ray Absorptiometry DIAGNOSTIC_TEST

Body composition measurement.

Also known as: DEXA

Lean Group; Obese Group

Muscle Biopsy PROCEDURE

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

Lean Group; Obese Group

Fat Biopsy PROCEDURE

Fat sample taken from abdomen

Lean Group; Obese Group

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.

Also known as: REE

Lean Group; Obese Group

Magnetic resonance imaging DIAGNOSTIC_TEST

MRI on upper leg to look at fat and muscle

Also known as: MRI

Lean Group; Obese Group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Sample of DNA stored for possible future research use at Mayo Clinic.

MeSH Terms

Conditions

Obesity

Interventions

Exercise Test; Absorptiometry, Photon; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques; Radiography; Diagnostic Imaging; Densitometry; Photometry; Chemistry Techniques, Analytical; Tomography

Study Officials

• Ian Lanza, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Passehl

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 12, 2023
• Study Start: September 22, 2023
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)