The Effect of Oral Carnitine Supplementation on MRS-derived Mitochondrial Function
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.
|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|
- Change in Acylcarnitine/Carnitine ratio [ Time Frame: Baseline, One Month ] [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||June 2014|
|Study Completion Date:||December 2014|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02124590
|United States, North Carolina|
|Duke Center for Living|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||William E Kraus, MD||Duke University|