ObesityNCT04865965
Effects of a Single Bout of Exercise on Transcriptomics and Metabolomics in Adipose Tissue
A study testing Acute Bout of Exercise in people with Obesity and Metabolic Complication, run by Joslin Diabetes Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Metabolic Complication
- What is being tested?
- Acute Bout of Exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2021to 23 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Obesity, Metabolic Complication
- Being tested
- Acute Bout of Exercise
- Keywords
- adipose tissue transcriptomics, adipose tissue metabolomics, peripheral blood mononuclear cell transcriptomics, obesity, exercise
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute Bout of ExerciseProcedure or surgery
Exercising for 60 minutes at 55-60% of VO₂ peak
| Study group | Role | What they receive |
|---|---|---|
| Acute Bout of Exercise | Experimental | Exercising for 60 minutes at 55-60% of VO₂ peak Receives: Procedure: Acute Bout of Exercise |
| No Exercise | No intervention | No Exercise Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcriptome in white adipose tissue
Gene transcription changes in RNA-based expression within subcutaneous adipose tissue
Measured: Baseline; 2 hours
Metabolome in fat
Changes in concentration of metabolites within subcutaneous adipose tissue
Measured: Baseline; 2 hours
Secondary outcomes (1)
Transcriptomic changes in peripheral blood mononuclear cell in people with obesity
Gene transcription changes in RNA-based expression within peripheral blood mononuclear cells
Measured: Baseline; 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start27 May 2021
- Primary completion23 May 2024
- Study completion23 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Institute of Technology
- Responsible party
- Sponsor
- Investigators
- Roeland JW Middelbeek, MD, Principal investigator, Joslin Diabetes CenterLaurie Goodyear, PhD, Principal investigator, Joslin Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865965
- Sponsor's protocol ID
- STUDY00000139
- Status last verified
- Feb 2025
- First submitted
- 13 Apr 2021
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Single Bout of Exercise on Transcriptomics and Metabolomics in Adipose Tissue
- ClinicalTrials.gov ID
- NCT04865965
- Acronym / sponsor ID
- STUDY00000139
- Conditions
- Obesity, Metabolic Complication
- Keywords
- adipose tissue transcriptomics, adipose tissue metabolomics, peripheral blood mononuclear cell transcriptomics, obesity, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Collaborators
- Massachusetts Institute of Technology
- Study start
- 27 May 2021 (actual)
- Primary completion
- 23 May 2024 (actual)
- Study completion
- 23 May 2024 (actual)
- First posted
- 29 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute Bout of Exercise | Experimental | Procedure: Acute Bout of ExerciseExercising for 60 minutes at 55-60% of VO₂ peak |
| No Exercise | No intervention | –No Exercise Session |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute Bout of ExerciseExercising for 60 minutes at 55-60% of VO₂ peak | Procedure or surgery | Acute Bout of Exercise |
Primary outcome
Transcriptome in white adipose tissue
Time frame: Baseline; 2 hours
Gene transcription changes in RNA-based expression within subcutaneous adipose tissue
Metabolome in fat
Time frame: Baseline; 2 hours
Changes in concentration of metabolites within subcutaneous adipose tissue
1 secondary outcome
Transcriptomic changes in peripheral blood mononuclear cell in people with obesity
Time frame: Baseline; 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roeland JW Middelbeek, MD principal investigator
Joslin Diabetes Center
Laurie Goodyear, PhD principal investigator
Joslin Diabetes Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute Bout of Exercise in people with Obesity and Metabolic Complication, run by Joslin Diabetes Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcriptome in white adipose tissue (time frame: Baseline; 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.