The Effect of Oral Carnitine Supplementation on MRS-derived Mitochondrial Function

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. Read our disclaimer for details. Identifier: NCT02124590
Recruitment Status : Completed
First Posted : April 28, 2014
Last Update Posted : June 17, 2015
Information provided by (Responsible Party):
Duke University

Brief Summary:
This is a longitudinal study supported by Pfizer and is a collaboration between DMPI (Duke Molecular Physiology Institute) and DIAL (Duke Image Acquisition Laboratory) to measure the effects of acute exercise on carnitine and acylcarnitine levels in the muscle and on insulin sensitivity in the plasma. This pilot study seeks to explain why moderate intensity exercise provides more improvements in glucose control for pre-diabetic patients than vigorous intensity. The investigators hypothesize that moderate intensity exercise might be beneficial for elderly individuals who are overweight or obese, specifically by: 1. Reducing damaging excess protein acetylation (measured in muscle biopsy), 2. Improving the acylcarnitine/carnitine ratio (measured by MRS), 3. Improving overall mitochondrial function as reflected in reduced phosphocreatine recovery time (measured by MRS) and 4. Increasing insulin sensitivity as measured by a 4-hour oral glucose tolerance test. Investigators intend to use the results of this study to show feasibility in measuring mitochondrial function at Duke for a larger federal grant submission. Investigators hypothesize that carnitine insufficiency might contribute to mitochondrial dysfunction and obesity-related impairments in glucose tolerance and insulin action.

Condition or disease Intervention/treatment Phase
Elderly Pre-diabetic Other: Acute Exercise Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Oral Carnitine Supplementation on MRS-derived Mitochondrial Function
Study Start Date : June 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Carnitine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Acute Exercise
Repeated isometric leg exercises at varying intensities and a second visit with aerobic bike exercise for 30 minutes at 50% peak VO2.
Other: Acute Exercise
Repeated isometric leg exercises at varying intensities for up to twelve minutes per bout. Leg exercises will target the quadriceps muscles.
Other: Acute Exercise
Aerobic exercise session on a bike at 50% of peak VO2 for 30 minutes.

Primary Outcome Measures :
  1. Change in Acylcarnitine/Carnitine ratio [ Time Frame: Baseline, One Month ]

Secondary Outcome Measures :
  1. Change in Protein acetylation [ Time Frame: Baseline, One Month ]
  2. Change in Insulin Sensitivity [ Time Frame: Baseline, One Month ]
  3. Change in Mitochondrial Function [ Time Frame: Baseline, One Month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age: 60-80 years
  • Moderately Overweight: BMI - 25.0 - 35.4
  • Sedentary - exercise ≤ 1 day/week
  • Fasting plasma glucose: > 100 - < 126 mg/dL
  • Readings from two separate days

Exclusion Criteria:

  • Orthopedic limitations, musculoskeletal disease and/or injury
  • Allergic to xylocaine
  • Inability to give blood continuously through an intravenous catheter
  • Have a confounding medical condition that is progressive and unstable such as HIV, Hepatitis C, active cancer, and/or taking medications for those conditions that are likely to confound the assessment of pre-diabetes
  • Prior surgical operation within the past 6 months
  • Prior injury to the eye involving metallic objects or fragments
  • Prior injury involving a metallic object or foreign body (eg. BB, bullet, shrapnel, etc.)
  • Tattoos from the waist down to the feet
  • Any of the following implants or devices

    • Aneurysm clip
    • Cardiac pacemaker
    • Implanted cardioverter defibrillator (ICD)
    • Electronic implant or device
    • Magnetically activated implant or device
    • Neurostimulation system
    • Spinal cord stimulator
    • Internal electrodes or wires
    • Bone growth/bone fusion stimulator
    • Cochlear, otologic or other ear implant
    • Insulin or other infusion pump
    • Implanted drug infusion device
    • Eye implants
    • Vascular access port and/or catheter
    • Wire mesh implant or stent
    • Other implant
  • Claustrophobia
  • Prior knee replacement surgery
  • Pregnant or intending to become pregnant during the study

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): NCT02124590

United States, North Carolina
Duke Center for Living
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Principal Investigator: William E Kraus, MD Duke University

Responsible Party: Duke University Identifier: NCT02124590     History of Changes
Other Study ID Numbers: Pro00053117
First Posted: April 28, 2014    Key Record Dates
Last Update Posted: June 17, 2015
Last Verified: June 2015

Keywords provided by Duke University:
Exercise Intensity
Insulin Sensitivity

Additional relevant MeSH terms:
Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases