Exercise and Insulin Signaling in Human Skeletal Muscle

NCT ID: NCT02987491

Last Updated: 2019-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-06-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Study Overview: We are investigating the mechanisms by which exercise improves the response of skeletal muscle to insulin in lean and obese adults. Participants will complete 4 study visits consisting of: 1) screening visit, 2) maximal exercise test visit, and then a randomized order of 3) a resting metabolic study visit, and 4) an exercise metabolic study visit. Metabolic study visits for resting and exercise conditions will be identical, other than remaining sedentary or performing exercise. Skeletal muscle biopsy samples will be collected during resting, immediately post-exercise and during insulin stimulated conditions.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Insulin Sensitivity Obesity Sedentary Lifestyle

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Exercise Metabolic Study Day

Participants 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.

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

Participants will perform 2 metabolic study days of either resting or acute bout of cycling exercise in a randomized cross-over design.

Resting Metabolic Study Day

Participants 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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Exercise

Participants will perform 2 metabolic study days of either resting or acute bout of cycling exercise in a randomized cross-over design.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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)

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Oregon State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Matthew Robinson, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon State University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Oregon State University

Corvallis, Oregon, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 34127633 (View on PubMed)

Stierwalt 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.

Reference Type DERIVED
PMID: 32796254 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

7605

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Training Effects on Fuel Metabolism
NCT02150889 ACTIVE_NOT_RECRUITING NA
Muscle Insulin Resistance in Aging (Mirage)
NCT02230839 ACTIVE_NOT_RECRUITING NA
Exercise Physiology Study
NCT03090451 COMPLETED NA