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Exercise and Insulin Signaling in Human Skeletal Muscle

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ClinicalTrials.gov Identifier: NCT02987491
Recruitment Status : Recruiting
First Posted : December 9, 2016
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Oregon State University

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.

Condition or disease Intervention/treatment Phase
Insulin Sensitivity Obesity Sedentary Lifestyle Behavioral: Exercise Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Exercise and Insulin Signaling in Human Skeletal Muscle
Study Start Date : November 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.

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

No Intervention: 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.




Primary Outcome Measures :
  1. Skeletal muscle insulin sensitivity [ Time Frame: 2 hours following rest or exercise ]
    Skeletal muscle insulin sensitivity will be measured by hyperinsulinemic-euglycemic clamp.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02987491


Contacts
Contact: Matthew Robinson, PhD 541-737-1988 TMR.Lab@oregonstate.edu

Locations
United States, Oregon
Oregon State University Recruiting
Corvallis, Oregon, United States, 97331
Contact: Matthew Robinson, PhD    541-737-1988    TMR.Lab@oregonstate.edu   
Principal Investigator: Matthew Robinson, PhD         
Principal Investigator: Sean Newsom, PhD         
Sponsors and Collaborators
Oregon State University
Investigators
Principal Investigator: Matthew Robinson, PhD Oregon State University

Responsible Party: Oregon State University
ClinicalTrials.gov Identifier: NCT02987491     History of Changes
Other Study ID Numbers: 7605
First Posted: December 9, 2016    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Oregon State University:
exercise

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs