Epigenetic Effects of a Single Bout of Exercise on Cardiovascular Risk Factors and the Metabolome

Not Applicable

Completed

• Conditions: Obesity; Type 2 Diabetes; Acute Exercise; Cardiovascular Diseases
• Interventions: Behavioral: Acute exercise

• Registration Number: NCT05034380
• Lead Sponsor: East Carolina University

Brief Summary

The purpose of this study is to determine the ability of acute exercise to regulate fat metabolism in muscle of overweight and obese people compared to lean people.

Detailed Description

After being informed about the study details and possible risks and benefits, 15 overweight/obese and 15 lean participants gave written informed consent and were then screened and enrolled in the study. All participants then gave a muscle sample and ate a calorically controlled breakfast. Participants completed \~1 hour of cycling exercise on a stationary bike and gave a second muscle sample 4 hours after eating breakfast.

Study Timeline

• Study Start: 2014-09-14
• Primary Completion: 2015-10-06
• Study Completion: 2016-03-14
• Study First Submitted: 2020-09-16
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-28
• Last Update Submitted: 2021-08-28
• Study First Posted: 2021-09-05
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• healthy males that completed a physical examination with a State Licensed M.D. or D.O. within the past 2 years and completed a physical activity readiness questionnaire (PARQ), the International Physical Activity Questionnaires (IPAQ) and and a medical history questionnaire prior to the study

Read More

Exclusion Criteria

• any participants that had not had a physical examination by a State Licensed M.D. or D.O. within the past 2 years
• persons not considered "healthy" (with any previous medical diagnoses) or not medically cleared by a M.D. or D.O. to perform physical activity/exercise
• persons who are regularly physically active

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lean	Acute exercise	males aged 18-30 years with BMI \< 25
Overweight/Obese	Acute exercise	males aged 18-30 years with BMI \>= 25

Primary Outcome Measures

Name	Time	Method
Change from baseline in skeletal transcriptome	Baseline and immediately after acute cycling exercise	RNA-seq is a method used to quantify changes in all known messenger RNA levels in the genome, giving an assessment of whole genome gene transcription changes.
Change from baseline in skeletal muscle acylcarnitines	Baseline and immediately after acute cycling exercise	Metabolomics of skeletal muscle acylcarnitines is used as a measure of mitochondrial function by assessing long, medium and short chain acylcarnitine levels.
Change from baseline in skeletal muscle whole genome nucleosome maps	Baseline and immediately after acute cycling exercise	MNase-seq is a method used to determine the occupancy/location of nucleosomes throughout the entire genome, supporting evidence of alterations in epigenetic modifications occurring at specific genomic loci that affect nucleosome occupancy/location and possibly gene transcription or silencing.

Secondary Outcome Measures

Name	Time	Method
Triglycerides	Baseline and immediately after acute cycling exercise	Commercially validated and available colorimetric kits used to determine plasma triglyceride levels.
Glucose	Baseline and immediately after acute cycling exercise	Commercially validated and available colorimetric used to determine plasma glucose levels.
Free fatty acids	Baseline and immediately after acute cycling exercise	Commercially validated and available colorimetric kits used to determine plasma free fatty acid levels.
Insulin	Baseline and immediately after acute cycling exercise	Commercially validated and available ELISAs used to determine plasma insulin levels.
Cholesterol	Baseline and immediately after acute cycling exercise	Commercially validated and available colorimetric kits used to determine total cholesterol, HDL, LDL and VLDL levels in plasma.

Trial Locations

Locations (1)

Purdue University; 🇺🇸 West Lafayette, Indiana, United States