ObesityNCT05034380
Epigenetic Effects of a Single Bout of Exercise on Cardiovascular Risk Factors and the Metabolome
A study testing Acute exercise in people with Obesity and Type 2 Diabetes, run by East Carolina University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Type 2 Diabetes, Cardiovascular Diseases
- What is being tested?
- Acute exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2014to 14 Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epigenetic Effects of a Single Bout of Exercise on Cardiovascular Risk Factors and the Metabolome in Lean and Overweight or Obese Subjects
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.
Read the 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.
- Conditions
- Obesity, Type 2 Diabetes, Cardiovascular Diseases, Acute Exercise
- Being tested
- Acute exercise
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Lean | Active comparator | males aged 18-30 years with BMI < 25 Receives: Behavioral: Acute exercise |
| Overweight/Obese | Experimental | males aged 18-30 years with BMI >= 25 Receives: Behavioral: Acute exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and immediately after acute cycling exercise
Secondary outcomes (5)
Glucose
Commercially validated and available colorimetric used to determine plasma glucose levels.
Measured: Baseline and immediately after acute cycling exercise
Insulin
Commercially validated and available ELISAs used to determine plasma insulin levels.
Measured: Baseline and immediately after acute cycling exercise
Triglycerides
Commercially validated and available colorimetric kits used to determine plasma triglyceride levels.
Measured: Baseline and immediately after acute cycling exercise
Free fatty acids
Commercially validated and available colorimetric kits used to determine plasma free fatty acid levels.
Measured: Baseline and immediately after acute cycling exercise
Cholesterol
Commercially validated and available colorimetric kits used to determine total cholesterol, HDL, LDL and VLDL levels in plasma.
Measured: Baseline and immediately after acute cycling exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start14 Sep 2014
- Primary completion6 Oct 2015
- Study completion14 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All participants underwent the same exact study protocol on random days throughout the study period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Collaborators
- Purdue University, Louisiana State University Health Sciences Center Shreveport
- Responsible party
- Principal investigator, Jessica Ellis, East Carolina University
- Investigators
- Tara Henagan, PhD, Principal investigator, Purdue University, Louisiana State University Medical School at Shreveport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034380
- Sponsor's protocol ID
- AcuteExerciseNucleo
- Status last verified
- Aug 2021
- First submitted
- 16 Sep 2020
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epigenetic Effects of a Single Bout of Exercise on Cardiovascular Risk Factors and the Metabolome in Lean and Overweight or Obese Subjects
- ClinicalTrials.gov ID
- NCT05034380
- Acronym / sponsor ID
- AcuteExerciseNucleo
- Conditions
- Obesity, Type 2 Diabetes, Cardiovascular Diseases, Acute Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Collaborators
- Purdue University, Louisiana State University Health Sciences Center Shreveport
- Study start
- 14 Sep 2014 (actual)
- Primary completion
- 6 Oct 2015 (actual)
- Study completion
- 14 Mar 2016 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- All participants underwent the same exact study protocol on random days throughout the study period.
| Arm | Type | Receives |
|---|---|---|
| Lean | Active comparator | Behavioral: Acute exercisemales aged 18-30 years with BMI < 25 |
| Overweight/Obese | Experimental | Behavioral: Acute exercisemales aged 18-30 years with BMI >= 25 |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute exerciseAll 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. | Behavioural | Lean, Overweight/Obese |
Primary outcome
Change from baseline in skeletal muscle acylcarnitines
Time frame: 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 transcriptome
Time frame: 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 whole genome nucleosome maps
Time frame: 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.
5 secondary outcomes
Glucose
Time frame: Baseline and immediately after acute cycling exercise
Insulin
Time frame: Baseline and immediately after acute cycling exercise
Triglycerides
Time frame: Baseline and immediately after acute cycling exercise
Free fatty acids
Time frame: Baseline and immediately after acute cycling exercise
Cholesterol
Time frame: Baseline and immediately after acute cycling exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tara Henagan, PhD principal investigator
Purdue University, Louisiana State University Medical School at Shreveport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute exercise in people with Obesity and Type 2 Diabetes, run by East Carolina University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in skeletal muscle acylcarnitines (time frame: Baseline and immediately after acute cycling exercise). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.