Exercise Response in Humans With Obesity

Mayo Clinic

Status: Enrolling

Conditions: Obese

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

Study type: Observational

Funder types: Other

Identifiers

NCT05857150

22-012396

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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)

Trial design

120 participants in 2 patient groups

Lean Group

Description:

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).

Treatment:

Diagnostic Test: Resting Energy Expenditure

Diagnostic Test: Dual-Energy X-Ray Absorptiometry

Diagnostic Test: Magnetic resonance imaging

Diagnostic Test: Strength Test

Diagnostic Test: Treadmill Test

Procedure: Muscle Biopsy

Procedure: Fat Biopsy

Obese Group

Description:

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).

Treatment:

Diagnostic Test: Resting Energy Expenditure

Diagnostic Test: Dual-Energy X-Ray Absorptiometry

Diagnostic Test: Magnetic resonance imaging

Diagnostic Test: Strength Test

Diagnostic Test: Treadmill Test

Procedure: Muscle Biopsy

Procedure: Fat Biopsy