NCT02701751

Brief Summary

The primary purpose of this study is to examine the effects of chronic exercise training and an acute session of exercise on key risk factors associated with Metabolic Syndrome (e.g., glucose tolerance, blood lipid profile, and blood pressure) and alterations in subcutaneous adipose tissue structure and metabolic function in overweight adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jan 2016

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

Study Start

First participant enrolled

January 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 8, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2016

Completed
Last Updated

March 21, 2022

Status Verified

March 1, 2022

Enrollment Period

10 months

First QC Date

January 21, 2016

Last Update Submit

March 18, 2022

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • PPARg mRNA expression

    The study team will quantify the abundance of key adipogenic markers in adipose tissue biopsy samples

    change from baseline at 1 hour post exercise

  • Cytokine abundance in adipose tissue

    The study team will measure cytokine proteins in adipose tissue

    change from baseline at 1 hour post exercise

Secondary Outcomes (1)

  • Total Cholesterol

    change from baseline at 1 hour post exercise

Study Arms (1)

Exercise session

OTHER

Subjects will exercise at a moderate intensity for 60 minutes. There are no different arms in this study.

Other: Exercise session

Interventions

Exercise sessionOTHER

A blood sample and fat biopsy will be obtained before and after the 60 minute moderate exercise session. There is no drug or device intervention in this study.

Exercise session

Eligibility Criteria

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

You may qualify if:

  • Age: 18-40
  • Body Mass Index: 25-35 kg/m2
  • Regular exercisers: (≥4 days/wk of aerobic exercise; 30-60min/session at moderate and vigorous intensities)
  • Non-exercisers: no regularly planned exercise/physical activity
  • Women must have regularly occurring menses and must be premenopausal

You may not qualify if:

  • Blood pressure \> 140/90 mm Hg
  • Pregnant or lactating
  • Evidence/history of cardiovascular or metabolic disease
  • Medications known to affect lipid or glucose metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

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
Professor, Movement Science; Director, Substrate Metabolism Laboratory

Study Record Dates

First Submitted

January 21, 2016

First Posted

March 8, 2016

Study Start

January 1, 2016

Primary Completion

October 24, 2016

Study Completion

October 24, 2016

Last Updated

March 21, 2022

Record last verified: 2022-03

Locations

US(1)