Clinical trial NCT05034380: Epigenetic Effects of a Single Bout of Exercise on Cardiovascular Risk Factors and the Metabolome
Official title: Epigenetic Effects of a Single Bout of Exercise on Cardiovascular Risk Factors and the Metabolome in Lean and Overweight or Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Type 2 Diabetes
Cardiovascular Diseases
Acute Exercise
Lead sponsor: East Carolina University
Sponsor class: OTHER
Collaborators: name: Purdue University
name: Louisiana State University Health Sciences Center Shreveport
First posted: 2021-09-05
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participants underwent the same exact study protocol on random days throughout the study period.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

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

Primary outcomes:
measure: Change from baseline in skeletal muscle acylcarnitines
timeFrame: Baseline and immediately after acute cycling exercise
measure: Change from baseline in skeletal transcriptome
timeFrame: Baseline and immediately after acute cycling exercise
measure: Change from baseline in skeletal muscle whole genome nucleosome maps
timeFrame: Baseline and immediately after acute cycling exercise
Secondary outcomes:
measure: Glucose
timeFrame: Baseline and immediately after acute cycling exercise
measure: Insulin
timeFrame: Baseline and immediately after acute cycling exercise
measure: Triglycerides
timeFrame: Baseline and immediately after acute cycling exercise
measure: Free fatty acids
timeFrame: Baseline and immediately after acute cycling exercise
measure: Cholesterol
timeFrame: Baseline and immediately after acute cycling exercise
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University, Louisiana State University Medical School at Shreveport
name: Tara Henagan, PhD
role: PRINCIPAL_INVESTIGATOR
References: