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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Duke University
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT02124590
First received: April 24, 2014
Last updated: NA
Last verified: April 2014
History: No changes posted
  Purpose

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 carnitine supplementation and acute exercise on carnitine and acylcarnitine levels in the muscle and on insulin sensitivity in the plasma. This pilot study seeks to determine whether carnitine supplementation 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 Intervention Phase
Elderly
Pre-diabetic
Dietary Supplement: Carnitor
Other: Acute Exercise
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Oral Carnitine Supplementation on MRS-derived Mitochondrial Function

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Change in Acylcarnitine/Carnitine ratio [ Time Frame: Baseline, One Month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Protein acetylation [ Time Frame: Baseline, One Month ] [ Designated as safety issue: No ]
  • Change in Insulin Sensitivity [ Time Frame: Baseline, One Month ] [ Designated as safety issue: No ]
  • Change in Mitochondrial Function [ Time Frame: Baseline, One Month ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: June 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Carnitine Supplementation and Acute Exercise
2 grams of Carnitor, L-carnitine supplement tablets, daily for one month Repeated isometric leg exercises at varying intensities
Dietary Supplement: Carnitor
Other Name: L-Carnitine
Other: Acute Exercise
Repeated isometric leg exercises at varying intensities for up to twelve minutes per bout. Leg exercises will target the quadriceps muscles.

  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02124590

Contacts
Contact: Cris A Slentz, PhD 919-660-6743 cris.slentz@duke.edu

Locations
United States, North Carolina
Duke Center for Living Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Cris Slentz, PhD    919-660-6743    cris.slentz@duke.edu   
Sponsors and Collaborators
Duke University
Pfizer
Investigators
Principal Investigator: William E Kraus, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02124590     History of Changes
Other Study ID Numbers: Pro00053117
Study First Received: April 24, 2014
Last Updated: April 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Carnitine
Acylcarnitine
Exercise
Exercise Intensity
Insulin Sensitivity
Carnitine Supplementation

Additional relevant MeSH terms:
Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Carnitine
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014