- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04865965
Effects of a Single Bout of Exercise on Transcriptomics and Metabolomics in Adipose Tissue
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Joslin Diabetes Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Acute Bout of Exercise
Exercising for 60 minutes at 55-60% of VO₂ peak
|
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
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Roeland JW Middelbeek, MD, Joslin Diabetes Center
- Principal Investigator: Laurie Goodyear, PhD, Joslin Diabetes Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00000139
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Obesity
-
Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | Obesity and Obesity-related Medical ConditionsUnited States
-
Central Hospital, Nancy, FranceNot yet recruiting
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsCompletedOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | GLP-1 | Obesity and Obesity-related Medical Conditions | Ablation TechniquesUnited States
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
Clinical Trials on Acute Bout of Exercise
-
University of VirginiaCompletedAging WellUnited States
-
University of North Carolina, GreensboroNorth American Society for the Psychology of Sport and Physical ActivityCompletedCognitive PerformanceUnited States
-
University of Kansas Medical CenterCompletedStroke | High Intensity Interval ExerciseUnited States
-
German Diabetes CenterMaastricht UniversityCompletedLipid Metabolism Disorders | Insulin Resistance, DiabetesNetherlands, Germany
-
Rigshospitalet, DenmarkCompletedAlveolar-capillary Reserve After Exercise in Chronic Obstructive Pulmonary Disease (COPD) (COP-DTPA)Chronic Obstructive Pulmonary DiseaseDenmark
-
Taif UniversityCompletedOsteoarthritis, KneeSaudi Arabia
-
Riphah International UniversityCompleted
-
Taif UniversityKing Abdullah HospitalCompletedChronic Low-back PainSaudi Arabia
-
Joslin Diabetes CenterDaiichi Sankyo, Inc.Completed
-
Sun Yat-sen UniversityNot yet recruiting