Back to resultsMitochondrial Remodeling After Exercise
Primary Purpose
Overweight and Obesity, Insulin Resistance, Metabolic Disease
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Short-term Exercise Training
Sponsored by
About this trial
This is an interventional basic science trial for Overweight and Obesity
Eligibility Criteria
Inclusion Criteria:
- Age 18-45 years
- Body mass index (BMI) 18-45 kg/m2
- Sedentary (<1 hour of planned exercise per week)
Exclusion Criteria:
- 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
- Lidocaine allergy
- Certain medications
- Physical limitations that prevent safe or successful exercise completion
- Diminished capacity for consent
Sites / Locations
- Oregon State University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Pre-training Metabolic Study Visit
Post-training Metabolic Study Visit
Arm Description
Participants will first complete a pre-training metabolic study visit.
Participants will complete a second, identical metabolic study visit following 2-weeks of exercise training.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04103424
Brief Title
Mitochondrial Remodeling After Exercise
Official Title
Mitochondrial Remodeling After Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 23, 2019 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Insulin Resistance, Metabolic Disease, Mitochondrial Metabolism, Sedentary Lifestyle
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Non-Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pre-training Metabolic Study Visit
Arm Type
No Intervention
Arm Description
Participants will first complete a pre-training metabolic study visit.
Arm Title
Post-training Metabolic Study Visit
Arm Type
Experimental
Arm Description
Participants will complete a second, identical metabolic study visit following 2-weeks of exercise training.
Intervention Type
Behavioral
Intervention Name(s)
Short-term Exercise Training
Intervention Description
Participants will perform 2-weeks of supervised exercise training on a stationary bike.
Primary Outcome Measure Information:
Title
Change in skeletal muscle mitochondrial protein degradation peptide products
Description
Skeletal muscle mitochondrial protein degradation peptide products after 2-weeks of exercise training compared with before training.
Time Frame
After 2-weeks of exercise training compared with before training.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18-45 years
Body mass index (BMI) 18-45 kg/m2
Sedentary (<1 hour of planned exercise per week)
Exclusion Criteria:
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
Lidocaine allergy
Certain medications
Physical limitations that prevent safe or successful exercise completion
Diminished capacity for consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Newsom, PhD
Organizational Affiliation
Oregon State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matthew Robinson, PhD
Organizational Affiliation
Oregon State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon State University
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97331
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mitochondrial Remodeling After Exercise
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