- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03314506
Adipose Tissue Cellular Response to Exercise in Healthy Humans (FLOW)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age: 18-40
- Body Mass Index: 20-27 kg/m2
- Regular exercise (less than or equal to 3 days/week of aerobic exercise; 30-60 minutes/session at moderate and vigorous intensities)
- Women must have regularly occurring menses and must be premenopausal
Exclusion Criteria:
- Blood pressure greater than 140/90 mm Hg
- Pregnant or lactating
- Evidence/history of cardiovascular or metabolic disease
- Medications known to affect lipid or glucose metabolism, or inflammation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Trial
Subjects will need to come to the Substrate Metabolism Laboratory in the morning around 7:00 AM.
After about a 15-30 minute rest, the study team will collect a blood sample from the subject's hand or forearm.
The study team will also obtain a small sample of fat tissue from the area just underneath the skin near the belly button.
Next, subjects will exercise on a treadmill at a moderate intensity for about 1 hour.
Immediately after exercising the study team will collect a blood sample.
The subject will remain resting in the laboratory for 3 hours after exercise, and then the study team will collect another blood and fat tissue sample.
Upon completion, the subject will be provided a snack before leaving the laboratory.
|
Subjects will exercise on a treadmill for 1 hour at a moderate intensity (approximately 70% of their predicted VO2peak).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quantifying the change in markers of macrophage abundance in adipose tissue
Time Frame: 1 day
|
The stromovascular fraction will be isolated from subcutaneous lipo-aspirate samples by collagenase digestion and a series of filtration/wash steps (routinely performed by our lab). This isolation protocol has been optimized to yield the minimum number of stromal cells required to identify and recover the following cell populations by fluorescence-activated cell sorting (FACS), listed as cell surface stain = cell type: CD64+/CD11c+ = macrophages FACS will be performed at the University of Michigan Flow Cytometry Core, and sorted cells will be recovered for subsequent gene expression analysis using the StepOnePlus real time PCR system (Life Technologies) with fluorescent probe-based assays. |
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quantifying the change in markers of endothelial cell and pre-adipocytes in adipose tissue
Time Frame: 1 day
|
The stromovascular fraction will be isolated from subcutaneous lipo-aspirate samples by collagenase digestion and a series of filtration/wash steps (routinely performed by our lab). This isolation protocol has been optimized to yield the minimum number of stromal cells required to identify and recover the following cell populations by fluorescence-activated cell sorting (FACS), listed as cell surface stain = cell type: CD34+/CD31+ = endothelial cells FACS will be performed at the University of Michigan Flow Cytometry Core, and sorted cells will be recovered for subsequent gene expression analysis using the StepOnePlus real time PCR system (Life Technologies) with fluorescent probe-based assays. |
1 day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00131070
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Metabolic Disease
-
Yonsei UniversityUnknownCardiovascular Disease | Metabolic DiseaseKorea, Republic of
-
Clinical Nutrition Research Centre, SingaporeCompletedCardiovascular Disease | Metabolic Disease
-
San Diego State UniversityRecruitingBone Disease, MetabolicUnited States
-
Hospital Clinic of BarcelonaNovartisCompletedBone Disease, MetabolicSpain
-
The Hospital for Sick ChildrenRare Disease Foundation, Vancouver, CanadaCompleted
-
Istituto Ortopedico RizzoliCompletedOsteopenia | Bone Disease, MetabolicItaly
-
Shenzhen Center for Chronic Disease ControlCompletedNutrition Disorders | Genetic Predisposition to Disease | Metabolic DiseaseChina
-
National Institutes of Health Clinical Center (CC)CompletedVascular Diseases | Cancer | Metabolic Bone Disease | Inflammatory DiseaseUnited States
-
Istituto Ortopedico GaleazziUnknownPhysical Activity | Bone Disease, MetabolicItaly
-
Stanley Dudrick's Memorial HospitalCompletedMetabolic Bone DiseasePoland
Clinical Trials on Exercise
-
University of Kansas Medical CenterRecruiting
-
National Institute of Neurological Disorders and...TerminatedTraumatic Brain InjuryUnited States
-
University of Texas, El PasoRecruitingKnee Osteoarthritis | Knee Pain Chronic | Central Pain SyndromeUnited States
-
Toronto Rehabilitation InstituteCompletedAcute Myeloid LeukemiaCanada
-
University College CorkRecruitingDepressive Disorder, MajorIreland
-
Sahmyook UniversityRecruitingChronic Nonspecific Neck PainKorea, Republic of
-
University of AlbertaWomen and Children's Health Research Institute, CanadaRecruitingType 1 Diabetes | Post-menopauseCanada
-
Uskudar UniversityCompleted
-
Yuksek Ihtisas UniversityCompletedDementia | Frailty | Cognitive Function | Reaction Time | Aerobic Exercise | Balance ExerciseTurkey
-
National Taiwan Normal UniversityCompletedAging | Cognitive DeclineTaiwan