Recruiting NCT05857150
Exercise Response in Humans With Obesity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Treadmill Test, Strength Test, Dual-Energy X-Ray Absorptiometry, Muscle Biopsy.
- Who it may be relevant to
- Registry conditions: Obese. Basic parameters: 20 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
This study is being done to understand how chronic inflammation affects muscle function and responses to exercise.
Interventions
- 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. - 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. - Diagnostic test Magnetic resonance imaging
MRI on upper leg to look at fat and muscle
Primary outcome measures
- Change in muscle protein synthesis [Time frame: Baseline, post-exercise approximately 8 hours]
Secondary outcome measures (2)
- Change in mRNA expression of exercise responsive genes [Time frame: Baseline, post-exercise approximately 8 hours]
- Change in expression and activation (phosphorylation) of signaling proteins [Time frame: Baseline, post-exercise approximately 8 hours]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT05857150 · 22-012396