Skip to main content
OpenTrials
Completed

NCT Number: NCT02124590

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Elderly Behavior Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Hyperinsulinism Insulin Resistance Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Pre-diabetic

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Center for Living

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acute exercise

Other

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

Primary outcomes

  1. Change in Acylcarnitine/Carnitine ratio

    Time frame: Baseline, One Month

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Pfizer

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 28, 2014
Registry last updated
Jun 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.