Effects of a Single Bout of Exercise on Transcriptomics and Metabolomics in Adipose Tissue
1 other identifier
interventional
16
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started May 2021
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2021
CompletedFirst Posted
Study publicly available on registry
April 29, 2021
CompletedStudy Start
First participant enrolled
May 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 23, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 23, 2024
CompletedFebruary 24, 2025
February 1, 2025
3 years
April 13, 2021
February 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Transcriptome in white adipose tissue
Gene transcription changes in RNA-based expression within subcutaneous adipose tissue
Baseline; 2 hours
Metabolome in fat
Changes in concentration of metabolites within subcutaneous adipose tissue
Baseline; 2 hours
Secondary Outcomes (1)
Transcriptomic changes in peripheral blood mononuclear cell in people with obesity
Baseline; 2 hours
Study Arms (2)
Acute Bout of Exercise
EXPERIMENTALExercising for 60 minutes at 55-60% of VO₂ peak
No Exercise
NO INTERVENTIONNo Exercise Session
Interventions
Exercising for 60 minutes at 55-60% of VO₂ peak
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Joslin Diabetes Centerlead
- Massachusetts Institute of Technologycollaborator
Study Sites (1)
Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roeland JW Middelbeek, MD
Joslin Diabetes Center
- PRINCIPAL INVESTIGATOR
Laurie Goodyear, PhD
Joslin Diabetes Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2021
First Posted
April 29, 2021
Study Start
May 27, 2021
Primary Completion
May 23, 2024
Study Completion
May 23, 2024
Last Updated
February 24, 2025
Record last verified: 2025-02