Overweight and ObesityNCT04103424
Mitochondrial Remodeling After Exercise
A study testing Short-term Exercise Training in people with Overweight and Obesity and Insulin Resistance, run by Oregon State University at 1 site in United States.
Trial summary
Regulation of mitochondrial health in overweight and obese individuals may be impaired. The purpose of this study is to identify impairments in regulation of mitochondrial health within skeletal muscle and to determine if short-term exercise training (2-weeks) can reverse such impairments. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Insulin Resistance, Metabolic Disease
- What is being tested?
- Short-term Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2019to 3 Dec 2022
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-45 years
- Body mass index (BMI) 18-45 kg/m2
- Sedentary (<1 hour of planned exercise per week)
Who cannot join
- Regular exercise (>1 hour of planned exercise per week)
- Smoking, tobacco or nicotine use within the last 1-year
- Fasting glucose >126mg/dL
- Hypertension (systolic pressure >140 mmHg or diastolic pressure >90 mmHg)
- Chronic metabolic or cardiovascular health conditions
- Pregnant, nursing, irregular menses or post-menopausal
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- Lidocaine allergy
- Certain medications
- Physical limitations that prevent safe or successful exercise completion
- Diminished capacity for consent
Trial locations and contacts
1 site in 1 country.
About this study
Regulation of mitochondrial health in overweight and obese individuals may be impaired. The purpose of this study is to identify impairments in regulation of mitochondrial health within skeletal muscle and to determine if short-term exercise training (2-weeks) can reverse such impairments. The investigator's hypothesis is that pathways that serve to degrade poorly functioning mitochondria in overweight and obese individuals are down-regulated, but that short-term exercise training can restore these pathways to improve skeletal muscle mitochondrial function.
- Conditions
- Overweight and Obesity, Insulin Resistance, Metabolic Disease, Mitochondrial Metabolism, Sedentary Lifestyle
- Being tested
- Short-term Exercise Training
- Medical subject headings
- Overweight, Obesity, Insulin Resistance, Metabolic Diseases, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short-term Exercise TrainingBehavioural
Participants will perform 2-weeks of supervised exercise training on a stationary bike.
| Study group | Role | What they receive |
|---|---|---|
| Pre-training Metabolic Study Visit | No intervention | Participants will first complete a pre-training metabolic study visit. |
| Post-training Metabolic Study Visit | Experimental | Participants will complete a second, identical metabolic study visit following 2-weeks of exercise training. Receives: Behavioral: Short-term Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in skeletal muscle mitochondrial protein degradation peptide products
Skeletal muscle mitochondrial protein degradation peptide products after 2-weeks of exercise training compared with before training.
Measured: After 2-weeks of exercise training compared with before training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start23 Aug 2019
- Primary completion25 Nov 2020
- Study completion3 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and 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
- Crossover
- Model description
- Participants will be asked to complete 2 screening visits to determine eligibility. If participants remain eligible, they will be asked to complete 2 metabolic study visits, 1 before and 1 after 2 weeks of supervised exercise training on a stationary bike.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sean Newsom, Oregon State University
- Investigators
- Sean Newsom, PhD, Principal investigator, Oregon State UniversityMatthew Robinson, PhD, Principal investigator, Oregon State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103424
- Sponsor's protocol ID
- IRB-2019-0124
- Status last verified
- Feb 2024
- First submitted
- 23 Aug 2019
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitochondrial Remodeling After Exercise
- ClinicalTrials.gov ID
- NCT04103424
- Acronym / sponsor ID
- IRB-2019-0124
- Conditions
- Overweight and Obesity, Insulin Resistance, Metabolic Disease, Mitochondrial Metabolism, Sedentary Lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Oregon State UniversityUniversity, hospital or other
- Study start
- 23 Aug 2019 (actual)
- Primary completion
- 25 Nov 2020 (actual)
- Study completion
- 3 Dec 2022 (actual)
- First posted
- 25 Sep 2019 (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.
Regulation of mitochondrial health in overweight and obese individuals may be impaired. The purpose of this study is to identify impairments in regulation of mitochondrial health within skeletal muscle and to determine if short-term exercise training (2-weeks) can reverse such impairments. The investigator's hypothesis is that pathways that serve to degrade poorly functioning mitochondria in overweight and obese individuals are down-regulated, but that short-term exercise training can restore these pathways to improve skeletal muscle mitochondrial function.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be asked to complete 2 screening visits to determine eligibility. If participants remain eligible, they will be asked to complete 2 metabolic study visits, 1 before and 1 after 2 weeks of supervised exercise training on a stationary bike.
| Arm | Type | Receives |
|---|---|---|
| Pre-training Metabolic Study Visit | No intervention | –Participants will first complete a pre-training metabolic study visit. |
| Post-training Metabolic Study Visit | Experimental | Behavioral: Short-term Exercise TrainingParticipants will complete a second, identical metabolic study visit following 2-weeks of exercise training. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-45 years
- Body mass index (BMI) 18-45 kg/m2
- Sedentary (<1 hour of planned exercise per week)
Key exclusion criteria (10 listed)
- Regular exercise (>1 hour of planned exercise per week)
- Smoking, tobacco or nicotine use within the last 1-year
- Fasting glucose >126mg/dL
- Hypertension (systolic pressure >140 mmHg or diastolic pressure >90 mmHg)
- Chronic metabolic or cardiovascular health conditions
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 |
|---|---|---|
| Short-term Exercise TrainingParticipants will perform 2-weeks of supervised exercise training on a stationary bike. | Behavioural | Post-training Metabolic Study Visit |
Primary outcome
Change in skeletal muscle mitochondrial protein degradation peptide products
Time frame: After 2-weeks of exercise training compared with before training.
Skeletal muscle mitochondrial protein degradation peptide products after 2-weeks of exercise training compared with before training.
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 13 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Sean Newsom, PhD principal investigator
Oregon State University
Matthew Robinson, PhD principal investigator
Oregon State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short-term Exercise Training in people with Overweight and Obesity and Insulin Resistance, run by Oregon State 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 3 inclusion and 10 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 13 Feb 2024. 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 in skeletal muscle mitochondrial protein degradation peptide products (time frame: After 2-weeks of exercise training compared with before training.). 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 13 Feb 2024.