Effects of a Single Bout of Exercise on Transcriptomics and Metabolomics in Adipose Tissue

February 21, 2025 updated by: Joslin Diabetes Center
The purpose of this study is to determine the effects of a single bout of exercise on changes in the genes and small molecules in blood and fat tissue, before and after a bout of exercise. This research may contribute to a better understanding of the beneficial effects of exercise on the body.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The national and international prevalence of both obesity and type 2 diabetes has risen dramatically over the last few decades, increasing the need for new therapies to treat these conditions. An established treatment for type 2 diabetes and obesity are regular physical activity and exercise. It has been shown that one single session of exercise can lead to adaptations in the blood and in tissues that improve systemic homeostasis overtime; while acute changes in skeletal muscle also play a critical role in these effects, changes in the adipose tissue and in the peripheral mononuclear cells (PBMCs) that may also contribute to this improvement. However, the beneficial effects of exercise on metabolism through these other tissues have not been intensively investigated.

The investigators hypothesize that a single session of exercise will result in changes to white adipose tissue, including changes in metabolites and gene expression, as well as changes in PBMCs, and that these adaptations may play an important role to improve metabolic homeostasis.

This hypothesis stems from the investigator's animal-based studies, which have led to the exciting discoveries that 1) exercise training-induced adaptations to subcutaneous white adipose tissue (scWAT) result in significant improvements in whole-body glucose tolerance and insulin sensitivity (1), and 2) the mechanism for this effect may be due to auto-, para-, or endocrine effects of novel exercise-induced circulating factors coming from adipose tissue. Thus, being able to further understand, and potentially mimick, these exercise-induced changes to scWAT could lead to novel therapies for obesity and type 2 diabetes.

Given the great interest in exercise mimetics as treatments for diabetes and obesity, it is essential to determine if a single session of exercise alters metabolites as well as gene expression in the scWAT in human subjects with obesity. To determine if a single session of exercise leads to changes in PBMCs, PBMC transcriptomics will be analyzed. This analysis will determine how exercise affects the number of specific cell types in the blood that can regulate metabolic health.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Joslin Diabetes Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 20-60 years
  • Body mass index (BMI) ≥30.0 ± 0.1 and ≤40.0 ± 0.1 kg/m2
  • HbA1c ≤ 5.7 ± 0.1%
  • No history of diabetes (type 1 and type 2)
  • In good general health with no conditions that could influence the outcome of the trial, and in the judgment of the investigator is a good candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations
  • Willing to adhere to the protocol requirements for the duration of the study

Exclusion Criteria:

  • Exercises frequently i.e. ≥ 150 minutes per week of moderate intensity or ≥ 75 min high intensity.
  • Blood glucose rises ≥140mg/dl at 2 hours after OGTT on Visit 1
  • Use of weight loss medications (i.e. GLP-1 agonists)
  • Use of any medications related to diabetes
  • Use of beta-blockers
  • Use of anticoagulation and aspirin
  • Use of agents that affect hepatic glucose production such as beta adrenergic agonists, xanthine derivatives
  • Currently pregnant or breastfeeding
  • Current smoker
  • Heart or lung disease
  • Acute infection, including COVID-19 (current or recent infection of COVID-19 in the previous 3 months)
  • Any hospitalization due to COVID-19.
  • Severe hypertension (systolic >160 mmHg or diastolic >90 mmHg)
  • Inability to exercise for any reason
  • Any known contraindication to exercise testing based on current ACSM guidelines (5)

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Acute Bout of Exercise
Exercising for 60 minutes at 55-60% of VO₂ peak
Procedure: Acute Bout of Exercise
Exercising for 60 minutes at 55-60% of VO₂ peak
No Intervention: No Exercise
No Exercise Session

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Transcriptome in white adipose tissue
Time Frame: Baseline; 2 hours
Gene transcription changes in RNA-based expression within subcutaneous adipose tissue
Baseline; 2 hours
Metabolome in fat
Time Frame: Baseline; 2 hours
Changes in concentration of metabolites within subcutaneous adipose tissue
Baseline; 2 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Transcriptomic changes in peripheral blood mononuclear cell in people with obesity
Time Frame: Baseline; 2 hours
Gene transcription changes in RNA-based expression within peripheral blood mononuclear cells
Baseline; 2 hours

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Joslin Diabetes Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Massachusetts Institute of Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Roeland JW Middelbeek, MD, Joslin Diabetes Center
  • Principal Investigator: Laurie Goodyear, PhD, Joslin Diabetes Center

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 27, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 23, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 23, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00000139

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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