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Exercise and Insulin Signaling in Human Skeletal Muscle

Sponsor
Oregon State University (Other)
Overall Status
Completed
CT.gov ID
NCT02987491
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
19.8
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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
  • Behavioral: Exercise
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
20 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 :
Nov 1, 2016
Actual Primary Completion Date :
Jun 28, 2018
Actual Study Completion Date :
Jun 28, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Skeletal muscle insulin sensitivity [2 hours following rest or exercise]

    Skeletal muscle insulin sensitivity will be measured by hyperinsulinemic-euglycemic clamp.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oregon State University Corvallis Oregon United States 97331

Sponsors and Collaborators

  • Oregon State University

Investigators

  • Principal Investigator: Matthew Robinson, PhD, Oregon State University

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Oregon State University
ClinicalTrials.gov Identifier:
NCT02987491
Other Study ID Numbers:
  • 7605
First Posted:
Dec 9, 2016
Last Update Posted:
Aug 28, 2019
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Oregon State University
exercise
Additional relevant MeSH terms:
Insulin Resistance

Study Results

No Results Posted as of Aug 28, 2019