NCT02987491

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 9, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2018

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

1.7 years

First QC Date

November 21, 2016

Last Update Submit

August 23, 2019

Conditions

Keywords

exercise

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

EXPERIMENTAL

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

Resting Metabolic Study Day

NO INTERVENTION

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.

Interventions

ExerciseBEHAVIORAL

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

Exercise Metabolic Study Day

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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.

  • 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.

MeSH Terms

Conditions

Insulin ResistanceObesitySedentary BehaviorMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Matthew Robinson, PhD

    Oregon State University

    PRINCIPAL INVESTIGATOR

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

Locations