Exercise and Insulin Signaling in Human Skeletal Muscle
1 other identifier
interventional
20
1 country
1
Brief Summary
Obesity is associated with a decrease in skeletal muscle insulin sensitivity. Aerobic exercise can increase insulin sensitivity in the few hours following exercise, however the cellular mechanisms are not completely understood. The current project is to investigate mechanisms of exercise improvements to skeletal muscle insulin sensitivity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 21, 2016
CompletedFirst Posted
Study publicly available on registry
December 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2018
CompletedAugust 28, 2019
August 1, 2019
1.7 years
November 21, 2016
August 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Skeletal muscle insulin sensitivity
Skeletal muscle insulin sensitivity will be measured by hyperinsulinemic-euglycemic clamp.
2 hours following rest or exercise
Study Arms (2)
Exercise Metabolic Study Day
EXPERIMENTALParticipants will perform a single bout of moderate intensity exercise on a cycle ergometer for 60 minutes. A total of 3 muscle biopsies will be collected throughout the study day. Insulin sensitivity will be measured using a hyperinsulinemic-euglycemic clamp with glucose tracers.
Resting Metabolic Study Day
NO INTERVENTIONParticipants will rest quietly in bed for 60 minutes and resting energy metabolism will be measured with a ventilated hood. A total of 3 muscle biopsies will be collected throughout the study day. Insulin sensitivity will be measured using a hyperinsulinemic-euglycemic clamp with glucose tracers.
Interventions
Participants will perform 2 metabolic study days of either resting or acute bout of cycling exercise in a randomized cross-over design.
Eligibility Criteria
You may qualify if:
- Males or Females
- Aged 18-45 years
- Normal weight (body mass index \[BMI\] 18-26 kg/m2) or obese (BMI 30-46 kg/m2)
- Sedentary (\< 1 hour of planned physical activity per week for ≥ 6 months)
- Weight stable (\< 2 kg change in body mass for ≥ 6 months)
- Non-smokers (no tobacco or nicotine use for ≥ 1 year)
You may not qualify if:
- Hypertension (systolic blood pressure \>140 mmHg, diastolic blood pressure \> 90mmHg)
- Chronic health condition including diabetes, cardiovascular disease, treated hypertension, cancer, anemia, uncontrolled hyper- or hypothyroidism.
- Pregnant, nursing, irregular menses or post-menopausal (if female)
- Hyperglycemia (fasting glucose \>126 mg/dl)
- Hypercholesterolemia (fasting LDL\>140mg/dl)
- Hemoglobin \< 13.0 g/dl (males), \< 11.5 g/dl (females)
- Compromised renal function (outside 135-145 mmol/L sodium, 3.5-5.1 mmol/L potassium)
- Lidocaine allergy
- Medications including β-blockers, angiotensin converting enzyme inhibitors, insulin, thiazolidinediones, metformin, sulfonylureas, chronic non-steroidal anti-inflammatory use, anti-coagulant (e.g. warfarin), current antibiotics, opiates, monoamine oxidase inhibitors, benzodiazepines, or others that may impact the study outcomes
- Any physical limitation that prevents a participant from safely completing the exercise test
- Due to the risks associated with the current protocol, individuals with a diminished capacity to consent will be excluded. Similarly, due to the need for constant, accurate participant monitoring during metabolic study activities, participants will need to clearly understand verbal and written English. Participants who cannot clearly understand verbal and written English will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oregon State University
Corvallis, Oregon, 97331, United States
Related Publications (2)
Newsom SA, Stierwalt HD, Ehrlicher SE, Robinson MM. Substrate-Specific Respiration of Isolated Skeletal Muscle Mitochondria after 1 h of Moderate Cycling in Sedentary Adults. Med Sci Sports Exerc. 2021 Jul 1;53(7):1375-1384. doi: 10.1249/MSS.0000000000002615.
PMID: 34127633DERIVEDStierwalt HD, Ehrlicher SE, Robinson MM, Newsom SA. Skeletal Muscle ACSL Isoforms Relate to Measures of Fat Metabolism in Humans. Med Sci Sports Exerc. 2021 Mar 1;53(3):624-632. doi: 10.1249/MSS.0000000000002487.
PMID: 32796254DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew Robinson, PhD
Oregon State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2016
First Posted
December 9, 2016
Study Start
November 1, 2016
Primary Completion
June 28, 2018
Study Completion
June 28, 2018
Last Updated
August 28, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share