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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05857150
Other study ID # 22-012396
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 22, 2023
Est. completion date July 2029

Study information

Verified date September 2023
Source Mayo Clinic
Contact Rose A McCain
Phone 507-255-6770
Email bilderback.rose@mayo.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date July 2029
Est. primary completion date July 2029
Accepts healthy volunteers No
Gender All
Age group 20 Years to 45 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

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).
Strength Test
Measure the strength of leg muscles by kicking against a machine with resistance.
Dual-Energy X-Ray Absorptiometry
Body composition measurement.
Procedure:
Muscle Biopsy
Obtain a small piece of muscles from the upper part of the legs
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.
Magnetic resonance imaging
MRI on upper leg to look at fat and muscle

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change in mRNA expression of exercise responsive genes Measure messenger ribonucleic acids (mRNAs) expression on exercise responsive genes Baseline, post-exercise approximately 8 hours
Secondary Change in expression and activation (phosphorylation) of signaling proteins Phosphorylation is a common mechanism for the regulation of receptor function Baseline, post-exercise approximately 8 hours
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