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Exercise Response in Humans With Obesity

Sponsor
Mayo Clinic (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05857150
Collaborator
(none)
120
Enrollment
1
Location
72
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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

Study Design

Study Type:
Observational
Anticipated Enrollment :
120 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Exercise Response in Humans With Obesity
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2029
Anticipated Study Completion Date :
Jul 1, 2029

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in muscle protein synthesis [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 Outcome Measures

    1. Change in mRNA expression of exercise responsive genes [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 [Baseline, post-exercise approximately 8 hours]

      Phosphorylation is a common mechanism for the regulation of receptor function

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Ian Lanza, PhD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Ian R. Lanza, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT05857150
    Other Study ID Numbers:
    • 22-012396
    First Posted:
    May 12, 2023
    Last Update Posted:
    May 12, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Obesity

    Study Results

    No Results Posted as of May 12, 2023