Exercise Response in Humans With Obesity

Recruiting

• Conditions: Obese
• Interventions: 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

• Registration Number: NCT05857150
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-05-04
• Study First Posted: 2023-05-12
• Study Start: 2023-09-22
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-07
• Primary Completion: 2029-07
• Study Completion: 2029-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lean Group	Strength Test	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).
Lean Group	Dual-Energy X-Ray Absorptiometry	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).
Lean Group	Magnetic resonance imaging	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	Resting Energy Expenditure	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).
Lean Group	Resting Energy Expenditure	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).
Lean Group	Treadmill Test	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).
Lean Group	Muscle Biopsy	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).
Lean Group	Fat Biopsy	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	Muscle Biopsy	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).
Obese Group	Fat Biopsy	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).
Obese Group	Magnetic resonance imaging	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).
Obese Group	Treadmill Test	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).
Obese Group	Strength Test	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).
Obese Group	Dual-Energy X-Ray Absorptiometry	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).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change in mRNA expression of exercise responsive genes	Baseline, post-exercise approximately 8 hours	Measure messenger ribonucleic acids (mRNAs) expression on exercise responsive genes
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

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States