Metabolic Adaptations to Chronic and Acute Exercise in Overweight Adults (ATX-Study) (ATX)

March 18, 2022 updated by: Jeffrey F Horowitz, University of Michigan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects will be asked to complete the Substrate Metabolism Laboratory General Screening Questionnaire and American Heart Association Health/Fitness Questionnaire to determine if they are eligible to complete the preliminary testing procedures. If eligible, subjects will be asked to visit the Substrate Metabolism Laboratory to participate in the preliminary testing procedures (listed below) before participating in the experimental trial.

PRELIMINARY TESTING PROCEDURES:

  • Blood pressure, height and weight measurements
  • Body Composition Assessment (~20 min)
  • Exercise Fitness Test (~10 min)
  • Resting Metabolic Rate (RMR) measurement (~30 min)
  • 3 hour Oral Glucose Tolerance Test (OGTT)

EXPERIMENTAL TRIAL:

The evening before the experimental trial, subjects will eat a standardized dinner meal and snack. The meal and snack must be eaten at specific times as indicated by the research staff. After eating the snack, subjects will need to fast (no food or beverages - besides water) overnight.

Participants who exercise regularly will be instructed to exercise exactly 3 days before the experimental trial, and then abstain from their exercise training program until after the study is complete.

In the morning, subjects will return to the Substrate Metabolism Laboratory. The research team will collect a blood sample from the subject's hand or forearm and a small sample of fat tissue in the subject's abdomen with a needle. Next, subjects will exercise on a treadmill at a moderate intensity for about 1 hour. Immediately after exercising the research team will collect a second blood sample. Subjects will remain in the laboratory for 1 hour after exercising, and then the research team will collect another blood and fat tissue sample. Upon completion of the experimental trial, subjects will be provided a snack before leaving the laboratory.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

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

    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

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

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Exercise session
Subjects will exercise at a moderate intensity for 60 minutes. There are no different arms in this study.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PPARg mRNA expression
Time Frame: change from baseline at 1 hour post exercise
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
Time Frame: change from baseline at 1 hour post exercise
The study team will measure cytokine proteins in adipose tissue
change from baseline at 1 hour post exercise

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Cholesterol
Time Frame: change from baseline at 1 hour post exercise
Plasma concentrations of total- cholesterol will be measured.
change from baseline at 1 hour post exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

January 1, 2016

Primary Completion (Actual)

October 24, 2016

Study Completion (Actual)

October 24, 2016

Study Registration Dates

First Submitted

January 21, 2016

First Submitted That Met QC Criteria

March 7, 2016

First Posted (Estimate)

March 8, 2016

Study Record Updates

Last Update Posted (Actual)

March 21, 2022

Last Update Submitted That Met QC Criteria

March 18, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00102522

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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