ObeseNCT05857150
Exercise Response in Humans With Obesity
An observational study of Obese, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is being done to understand how chronic inflammation affects muscle function and responses to exercise. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Obese
- What is being tested?
- Treadmill Test, Strength Test and Dual-Energy X-Ray Absorptiometry
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2023to Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: Men and women ages 20-45 years with Body Mass Index 20-40
Who may be able to join
- Obese men and women ≥ 20 and ≤ 45 years of age.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Rachel Osland, 507-255-8112, Osland.Rachel@mayo.edu
About this study
This study is being done to understand how chronic inflammation affects muscle function and responses to exercise.
- Conditions
- Obese
- Being tested
- Treadmill Test, Strength Test, Dual-Energy X-Ray Absorptiometry, Muscle Biopsy, Fat Biopsy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill TestDiagnostic 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 TestDiagnostic test
Measure the strength of leg muscles by kicking against a machine with resistance.
Dual-Energy X-Ray AbsorptiometryDiagnostic test
Also called DEXA
Body composition measurement.
Muscle BiopsyProcedure or surgery
Obtain a small piece of muscles from the upper part of the legs
Fat BiopsyProcedure or surgery
Fat sample taken from abdomen
Resting Energy ExpenditureDiagnostic test
Also called REE
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 imagingDiagnostic test
Also called MRI
MRI on upper leg to look at fat and muscle
| Study group | Role | What they receive |
|---|---|---|
| Lean Group | 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). Receives: 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 | |
| Obese Group | 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). Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, post-exercise approximately 8 hours
Secondary outcomes (2)
Change in mRNA expression of exercise responsive genes
Measure messenger ribonucleic acids (mRNAs) expression on exercise responsive genes
Measured: Baseline, post-exercise approximately 8 hours
Change in expression and activation (phosphorylation) of signaling proteins
Phosphorylation is a common mechanism for the regulation of receptor function
Measured: Baseline, post-exercise approximately 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start22 Sep 2023
- Primary completionJul 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ian R. Lanza, Mayo Clinic
- Investigators
- Ian Lanza, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857150
- Sponsor's protocol ID
- 22-012396
- Status last verified
- Sep 2026
- First submitted
- 4 May 2023
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Response in Humans With Obesity
- ClinicalTrials.gov ID
- NCT05857150
- Acronym / sponsor ID
- 22-012396
- Conditions
- Obese
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 12 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to understand how chronic inflammation affects muscle function and responses to exercise.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lean Group | – | 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 imagingParticipants 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 | – | 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 imagingParticipants 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). |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Men and women ages 20-45 years with Body Mass Index 20-40
Key inclusion criteria (1 listed)
- Obese men and women ≥ 20 and ≤ 45 years of age.
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treadmill TestMeasurement 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 | Lean Group, Obese Group |
| Strength TestMeasure the strength of leg muscles by kicking against a machine with resistance. | Diagnostic test | Lean Group, Obese Group |
| Dual-Energy X-Ray AbsorptiometryAlso: DEXABody composition measurement. | Diagnostic test | Lean Group, Obese Group |
| Muscle BiopsyObtain a small piece of muscles from the upper part of the legs | Procedure or surgery | Lean Group, Obese Group |
| Fat BiopsyFat sample taken from abdomen | Procedure or surgery | Lean Group, Obese Group |
| Resting Energy ExpenditureAlso: REEMeasured 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 | Lean Group, Obese Group |
| Magnetic resonance imagingAlso: MRIMRI on upper leg to look at fat and muscle | Diagnostic test | Lean Group, Obese Group |
Primary outcome
Change in muscle protein synthesis
Time frame: 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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ian Lanza, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obese, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Osland (507-255-8112, Osland.Rachel@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in muscle protein synthesis (time frame: Baseline, post-exercise approximately 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.