- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02732509
Chronic Inflammation and Exercise Responsiveness
January 12, 2022 updated by: Ian R. Lanza, Mayo Clinic
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 Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
146
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- Age 30-55 years
- BMI 19-45 kg/m2
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
|---|
|
Lean
Body mass index less than 25 kg/m2
|
|
Overweight/obese
Body mass index 25-45 kg/m2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Maximal oxygen consumption rates in mitochondria isolated from skeletal muscles
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ian R Lanza, PhD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2016
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
March 22, 2016
First Submitted That Met QC Criteria
April 4, 2016
First Posted (Estimate)
April 8, 2016
Study Record Updates
Last Update Posted (Actual)
January 13, 2022
Last Update Submitted That Met QC Criteria
January 12, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-000437
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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