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

NCT05034380 | Completed DMC

• 1 other identifier: AcuteExerciseNucleo
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Type 2 Diabetes; Cardiovascular Diseases; Acute Exercise

Outcome Measures

Primary Outcomes (3)

• Change from baseline in skeletal muscle acylcarnitines

  Metabolomics of skeletal muscle acylcarnitines is used as a measure of mitochondrial function by assessing long, medium and short chain acylcarnitine levels.

  Baseline and immediately after acute cycling exercise

• Change from baseline in skeletal transcriptome

  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.

  Baseline and immediately after acute cycling exercise

• Change from baseline in skeletal muscle whole genome nucleosome maps

  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.

  Baseline and immediately after acute cycling exercise

Secondary Outcomes (5)

• Glucose

  Baseline and immediately after acute cycling exercise

• Insulin

  Baseline and immediately after acute cycling exercise

• Triglycerides

  Baseline and immediately after acute cycling exercise

• Free fatty acids

  Baseline and immediately after acute cycling exercise

• Cholesterol

  Baseline and immediately after acute cycling exercise

Study Arms (2)

Lean

ACTIVE COMPARATOR

males aged 18-30 years with BMI \< 25

Behavioral: Acute exercise

Overweight/Obese

EXPERIMENTAL

males aged 18-30 years with BMI \>= 25

Behavioral: Acute exercise

Interventions

Acute exercise BEHAVIORAL

All participants consumed a standardized, high carbohydrate meal (7 kcal/kg; 60% carbohydrate, 25% fat, 15% protein) and completed an exercise testing trial, expending a total of 650 kcal upon completion 4h later.

Lean; Overweight/Obese

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• East Carolina University: lead
• Purdue University: collaborator
• Louisiana State University Health Sciences Center Shreveport: collaborator

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Cardiovascular Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Tara Henagan, PhD

  Purdue University, Louisiana State University Medical School at Shreveport

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Investigators conducting molecular analysis were blinded to study samples/groups.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: All participants underwent the same exact study protocol on random days throughout the study period.

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 5, 2021
• Study Start: September 14, 2014
• Primary Completion: October 6, 2015
• Study Completion: March 14, 2016
• Last Updated: September 5, 2021

Record last verified: 2021-08

Locations

US (1)