NCT03314506

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 19, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2019

Completed
Last Updated

March 21, 2022

Status Verified

March 1, 2022

Enrollment Period

1.8 years

First QC Date

September 27, 2017

Last Update Submit

March 18, 2022

Conditions

Keywords

exercise

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 day

Secondary Outcomes (1)

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

    1 day

Study Arms (1)

Trial

EXPERIMENTAL

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.

Other: Exercise

Interventions

Subjects will exercise on a treadmill for 1 hour at a moderate intensity (approximately 70% of their predicted VO2peak).

Trial

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Metabolic DiseasesMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jeffrey F Horowitz

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Movement Science, School of Kinesiology

Study Record Dates

First Submitted

September 27, 2017

First Posted

October 19, 2017

Study Start

November 1, 2017

Primary Completion

August 8, 2019

Study Completion

August 8, 2019

Last Updated

March 21, 2022

Record last verified: 2022-03

Locations