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

Primary Purpose

Elderly, Pre-diabetic

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Acute Exercise

About this trial

This is an interventional treatment trial for Elderly focused on measuring Carnitine, Acylcarnitine, Exercise, Exercise Intensity, Insulin Sensitivity

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Duke Center for Living

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acute Exercise

Arm Description

Repeated isometric leg exercises at varying intensities and a second visit with aerobic bike exercise for 30 minutes at 50% peak VO2.

Outcomes

Primary Outcome Measures

Change in Acylcarnitine/Carnitine ratio

Secondary Outcome Measures

Change in Protein acetylation

Change in Insulin Sensitivity

Change in Mitochondrial Function

Full Information

NCT ID

NCT02124590

First Posted

April 24, 2014

Last Updated

June 15, 2015

Sponsor

Duke University

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT02124590

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

June 2014 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Elderly, Pre-diabetic

Keywords

Carnitine, Acylcarnitine, Exercise, Exercise Intensity, Insulin Sensitivity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acute Exercise

Arm Type

Experimental

Arm Description

Repeated isometric leg exercises at varying intensities and a second visit with aerobic bike exercise for 30 minutes at 50% peak VO2.

Intervention Type

Other

Intervention Name(s)

Acute Exercise

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Acute Exercise

Intervention Description

Aerobic exercise session on a bike at 50% of peak VO2 for 30 minutes.

Primary Outcome Measure Information:

Title

Change in Acylcarnitine/Carnitine ratio

Time Frame

Baseline, One Month

Secondary Outcome Measure Information:

Title

Change in Protein acetylation

Time Frame

Baseline, One Month

Title

Change in Insulin Sensitivity

Time Frame

Baseline, One Month

Title

Change in Mitochondrial Function

Time Frame

Baseline, One Month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William E Kraus, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke Center for Living

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

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

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