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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02124590
Enrollment
14
Registered
2014-04-28
Start date
2014-06-30
Completion date
2014-12-31
Last updated
2015-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly, Pre-diabetic

Keywords

Carnitine, Acylcarnitine, Exercise, Exercise Intensity, Insulin Sensitivity

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.

Interventions

OTHERAcute Exercise

Repeated isometric leg exercises at varying intensities for up to twelve minutes per bout. Leg exercises will target the quadriceps muscles.

Sponsors

Pfizer
CollaboratorINDUSTRY
Duke University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frame
Change in Acylcarnitine/Carnitine ratioBaseline, One Month

Secondary

MeasureTime frame
Change in Protein acetylationBaseline, One Month
Change in Insulin SensitivityBaseline, One Month
Change in Mitochondrial FunctionBaseline, One Month

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026