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Adipose Tissue Cellular Response to Exercise in Healthy Humans (FLOW)

Primary Purpose

Metabolic Disease, Adipose Tissue

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metabolic Disease focused on measuring exercise

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Trial

Arm Description

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.

Outcomes

Primary Outcome Measures

Quantifying the change in markers of macrophage abundance in adipose tissue
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.

Secondary Outcome Measures

Quantifying the change in markers of endothelial cell and pre-adipocytes in adipose tissue
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.

Full Information

First Posted
September 27, 2017
Last Updated
March 18, 2022
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT03314506
Brief Title
Adipose Tissue Cellular Response to Exercise in Healthy Humans
Acronym
FLOW
Official Title
Adipose Tissue Cellular Response to Exercise in Healthy Humans
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
August 8, 2019 (Actual)
Study Completion Date
August 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to measure the effects of a single session of exercise on changes in the cellular composition of the body fat of humans.
Detailed Description
Fat tissue is far more than just a place where humans store body fat. Fat tissue contains many different types of cells, such as immune cells, endothelial cells, and fat precursor cells. Differences or changes in the number of immune cells, endothelial cells, and fat precursor cells in fat tissue can have a great impact on metabolic health. The abundance of all immune cells, endothelial cells, and fat precursor cell types are known to change when a person loses or gains weight. For example, the abundance of inflammatory cells is often found to decrease markedly with weight loss - and this change has been linked to the profound improvements in metabolic health that occur with weight loss. In contrast, the effects of exercise on immune cells, endothelial cells, and fat precursor cells in fat tissue is not known. Determining the effects of exercise on changes in the cellular composition within fat tissue will provide important information for optimizing lifestyle interventions aimed at improving metabolic health.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Disease, Adipose Tissue
Keywords
exercise

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trial
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Subjects will exercise on a treadmill for 1 hour at a moderate intensity (approximately 70% of their predicted VO2peak).
Primary Outcome Measure Information:
Title
Quantifying the change in markers of macrophage abundance in adipose tissue
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Quantifying the change in markers of endothelial cell and pre-adipocytes in adipose tissue
Description
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.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey F Horowitz
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

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Adipose Tissue Cellular Response to Exercise in Healthy Humans

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