Metabolic SyndromeNCT02732509
Chronic Inflammation and Exercise Responsiveness
An observational study of Metabolic Syndrome, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine how chronic inflammation influences skeletal muscle protein metabolism and metabolic function in humans. The investigators will evaluate acute responsiveness to a single bout of exercise in men and women who are either lean or overweight/obese. Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Men and women between the ages of 30-55 years will be recruited for this study. Fifteen individuals will be lean, defined as a body mass index (BMI) between 19 and 24 kg/m2. Thirty individuals will be overweight/obese, defined as a BMI between 25 and 45 kg/m2.
Who may be able to join
- Age 30-55 years
- BMI 19-45 kg/m2
Who cannot join
- 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 insufficiency/failure (serum creatinine > 1.5mg/dl)
- Oral warfarin group medications or history of blood clotting disorders.
- Pregnancy or breastfeeding
- Alcohol consumption greater than 2 glasses/day or other substance abuse
- Untreated or uncontrolled thyroid disorders
- Debilitating chronic disease (at the discretion of the investigators)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine how chronic inflammation influences skeletal muscle protein metabolism and metabolic function in humans. The investigators will evaluate acute responsiveness to a single bout of exercise in men and women who are either lean or overweight/obese. The investigators will explore the relationship between circulating inflammatory markers and anabolic, proteomic, and transcriptional responses to acute exercise. The investigators will measure skeletal muscle protein synthesis in the postabsorptive state and in response to a single bout of exercise.
- Conditions
- Metabolic Syndrome
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lean | Body mass index less than 25 kg/m2 | |
| Overweight/obese | Body mass index 25-45 kg/m2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal oxygen consumption rates in mitochondria isolated from skeletal muscles
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2016 (estimated)
- Study startMar 2016
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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
- Cross-sectional
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ian R. Lanza, Mayo Clinic
- Investigators
- Ian R Lanza, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732509
- Sponsor's protocol ID
- 16-000437
- Status last verified
- Jan 2022
- First submitted
- 22 Mar 2016
- Last updated
- 13 Jan 2022
- Results posted
- No
Publications
Vanderboom P, Zhang X, Hart CR, Kunz HE, Gries KJ, Heppelmann CJ, Liu Y, Dasari S, Lanza IR. Impact of obesity on the molecular response to a single bout of exercise in a preliminary human cohort. Obesity (Silver Spring). 2022 May;30(5):1091-1104. doi: 10.1002/oby.23419.
PubMed 35470975
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Inflammation and Exercise Responsiveness
- ClinicalTrials.gov ID
- NCT02732509
- Acronym / sponsor ID
- 16-000437
- Conditions
- Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 8 Apr 2016 (estimated)
- 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.
The purpose of this study is to determine how chronic inflammation influences skeletal muscle protein metabolism and metabolic function in humans. The investigators will evaluate acute responsiveness to a single bout of exercise in men and women who are either lean or overweight/obese. The investigators will explore the relationship between circulating inflammatory markers and anabolic, proteomic, and transcriptional responses to acute exercise. The investigators will measure skeletal muscle protein synthesis in the postabsorptive state and in response to a single bout of exercise.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lean | – | –Body mass index less than 25 kg/m2 |
| Overweight/obese | – | –Body mass index 25-45 kg/m2 |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Men and women between the ages of 30-55 years will be recruited for this study. Fifteen individuals will be lean, defined as a body mass index (BMI) between 19 and 24 kg/m2. Thirty individuals will be overweight/obese, defined as a BMI between 25 and 45 kg/m2.
Key inclusion criteria (2 listed)
- Age 30-55 years
- BMI 19-45 kg/m2
Key exclusion criteria (8 listed)
- 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 insufficiency/failure (serum creatinine > 1.5mg/dl)
- Oral warfarin group medications or history of blood clotting disorders.
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maximal oxygen consumption rates in mitochondria isolated from skeletal muscles
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Derived from this study: PubMed 35470975Vanderboom P, Zhang X, Hart CR, Kunz HE, Gries KJ, Heppelmann CJ, Liu Y, Dasari S, Lanza IR. Impact of obesity on the molecular response to a single bout of exercise in a preliminary human cohort. Obesity (Silver Spring). 2022 May;30(5):1091-1104. doi: 10.1002/oby.23419.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Ian R 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 Metabolic Syndrome, 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 2 inclusion and 8 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: finished, as of the sponsor's last update on 13 Jan 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal oxygen consumption rates in mitochondria isolated from skeletal muscles (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02732509, which also lists 1 linked publication.
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 13 Jan 2022.