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Mechanisms of Skeletal Muscle Insulin Resistance in Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02971098
Recruitment Status : Recruiting
First Posted : November 22, 2016
Last Update Posted : April 17, 2019
Information provided by (Responsible Party):
Micah Drummond, University of Utah

Brief Summary:

The over-65 population is not only increasing at an alarming rate, but because six out of 10 will be managing more than one chronic condition by 2030, they will make up a much greater proportion of hospitalizations than ever before. Hospitalizations for disease, injury, and/or surgery in this group are likely to impair physical mobility and, therefore, the older adults capacity to be physically active both during hospitalization and beyond. The resulting sedentary lifestyle is likely to be accepted as the "new normal", ultimately increasing the risk of skeletal muscle and metabolic dysfunction (e.g. impaired glucose disposal, insulin resistance). These devastating outcomes are neither inevitable nor necessary if prevented with an appropriate mechanism-based intervention.

A novel mechanism that may contribute to physical inactivity-induced insulin resistance is accumulation of inflammation and ceramide within skeletal muscle. Of interest, increased skeletal muscle inflammation and ceramide has been tied to various metabolic disturbances such as diabetes and insulin resistance. However, it is currently unknown if skeletal muscle inflammation and ceramide are a key mechanism associated with insulin resistance due to physical inactivity in older adults.

Condition or disease Intervention/treatment Phase
Reduced Physical Activity Procedure: Reduced activity Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 2 weeks of physical inactivity
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Novel Molecular Mechanisms of Skeletal Muscle Insulin, Resistance if Physically Inactive Older Adults
Study Start Date : September 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2021

Arm Intervention/treatment
Experimental: Reduced activity
participants will undergo a reduced physical activity period (75% step reduction) for two weeks.
Procedure: Reduced activity
Participants will reduced their physical activity level to approximately 2000 steps or 75% of their normal activity levels.

Primary Outcome Measures :
  1. Steady state glucose infusion rate [ Time Frame: percent change from baseline at 14 days ]
    Glucose infusion rate will be determined by a hyperinsulinemic-euglycemic clamp

Secondary Outcome Measures :
  1. lean mass [ Time Frame: percent change from baseline at 14 days ]
    lean mass will be determined by DXA scan

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age between 60-85 yrs
  • Ability to sign informed consent
  • Free-living, prior to admission

Exclusion Criteria:

  • The participant must not have participated in any previous research studies utilizing ionizing radiation (either radioisotopes or diagnostic x-rays) during the past 12 months in order to participate in this study. Cardiac abnormalities considered exclusionary by the study physician
  • Uncontrolled endocrine or metabolic disease (e.g., hypo/hyperthyroidism, diabetes)
  • History of kidney disease or failure
  • Vascular disease or risk factors of peripheral atherosclerosis. (e.g., uncontrolled hypertension, obesity, diabetes, hypercholesterolemia > 250 mg/dl, claudication or evidence of venous or arterial insufficiency upon palpitation of femoral, popliteal and pedal arteries)
  • Risk of deep vein thrombosis (DVT) including family history of thrombophilia, DVT, pulmonary emboli, myeloproliferative diseases including polycythemia (Hb>18 g/dL) or thrombocytosis (platelets>400x103/mL), and connective tissue diseases (positive lupus anticoagulant), hyperhomocysteinemia, deficiencies of factor V Leiden, proteins S and C, and antithrombin III
  • Use of anticoagulant therapy (e.g., Coumadin, heparin)
  • Elevated systolic pressure >150 or a diastolic blood pressure > 100
  • Implanted electronic devices (e.g., pacemakers, electronic infusion pumps, stimulators)
  • Cancer or history of successfully treated cancer (less than 1 year) other than basal cell carcinoma
  • Currently on a weight-loss diet or body mass index > 30 kg/m2
  • Recent anabolic or corticosteroids use (within 3 months)
  • History of stroke with motor disability
  • A recent history (<12 months) of GI bleed
  • Exercise training (>2 session of moderate to high intensity aerobic or resistance exercise/week)
  • History of liver disease
  • History of respiratory disease (acute upper respiratory infection, history of chronic lung disease)
  • Prior history of Heparin-Induced Thrombocytopenia (HIT)
  • Any other condition or event considered exclusionary by the PI and faculty physician
  • An HbA1c value at or greater than 6.5%
  • Subjects may not participate if they have utilized ionizing radiation (either radioisotopes or diagnostic x-rays) during the past 12 months

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 identifier (NCT number): NCT02971098

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Contact: Amy Rogers 801-585-5961
Contact: Micah Drummond 801-585-1310

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United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Amy Rogers    801-581-5961   
Sponsors and Collaborators
University of Utah
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Principal Investigator: Micah J Drummond, PhD University of Utah

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Responsible Party: Micah Drummond, Ph.D., University of Utah Identifier: NCT02971098     History of Changes
Other Study ID Numbers: 84354
First Posted: November 22, 2016    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No