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

Elderly Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02124590
• Other study ID #: Pro00053117
• Status: Completed
• Phase: N/A
• First received: April 24, 2014
• Last updated: June 15, 2015
• Start date: June 2014
• Est. completion date: December 2014

Study information

• Verified date: June 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 80 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Elderly
• Pre-diabetic
• Prediabetic State

Intervention

Other:
• Acute Exercise
Repeated isometric leg exercises at varying intensities for up to twelve minutes per bout. Leg exercises will target the quadriceps muscles.
• Acute Exercise
Aerobic exercise session on a bike at 50% of peak VO2 for 30 minutes.

Locations

Country	Name	City	State
United States	Duke Center for Living	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Acylcarnitine/Carnitine ratio		Baseline, One Month	No
Secondary	Change in Protein acetylation		Baseline, One Month	No
Secondary	Change in Insulin Sensitivity		Baseline, One Month	No
Secondary	Change in Mitochondrial Function		Baseline, One Month	No