Exercise Response in Humans With Obesity

Obese Clinical Trial

Official title:

Exercise Response in Humans With Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05857150
• Other study ID #: 22-012396
• Status: Recruiting
• 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
• 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)

Related Conditions & MeSH terms

• Obese
• Obesity

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

External Links

•   Mayo Clinic Clinical Trials