Exercise Response in Humans With Obesity

NCT ID: NCT05857150

Last Updated: 2025-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-22

Study Completion Date

2029-07-31

Brief Summary

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

Detailed Description

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Conditions

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Obese

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

Treadmill Test

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

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

Dual-Energy X-Ray Absorptiometry

Intervention Type DIAGNOSTIC_TEST

Body composition measurement.

Muscle Biopsy

Intervention Type PROCEDURE

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

Fat Biopsy

Intervention Type PROCEDURE

Fat sample taken from abdomen

Resting Energy Expenditure

Intervention Type 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.

Magnetic resonance imaging

Intervention Type DIAGNOSTIC_TEST

MRI on upper leg to look at fat and muscle

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).

Treadmill Test

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

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

Dual-Energy X-Ray Absorptiometry

Intervention Type DIAGNOSTIC_TEST

Body composition measurement.

Muscle Biopsy

Intervention Type PROCEDURE

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

Fat Biopsy

Intervention Type PROCEDURE

Fat sample taken from abdomen

Resting Energy Expenditure

Intervention Type 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.

Magnetic resonance imaging

Intervention Type DIAGNOSTIC_TEST

MRI on upper leg to look at fat and muscle

Interventions

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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).

Intervention Type DIAGNOSTIC_TEST

Strength Test

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

Intervention Type DIAGNOSTIC_TEST

Dual-Energy X-Ray Absorptiometry

Body composition measurement.

Intervention Type DIAGNOSTIC_TEST

Muscle Biopsy

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

Intervention Type PROCEDURE

Fat Biopsy

Fat sample taken from abdomen

Intervention Type PROCEDURE

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.

Intervention Type DIAGNOSTIC_TEST

Magnetic resonance imaging

MRI on upper leg to look at fat and muscle

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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DEXA REE MRI

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Ian R. Lanza

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ian Lanza, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Rachel Passehl

Role: CONTACT

507-255-8112

Facility Contacts

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Rachel Passehl

Role: primary

507-255-8112

Other Identifiers

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22-012396

Identifier Type: -

Identifier Source: org_study_id

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