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

NCT02124590 | Completed

• 1 other identifier: Pro00053117
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Elderly; Pre-diabetic

Keywords

Carnitine; Acylcarnitine; Exercise; Exercise Intensity; Insulin Sensitivity

Outcome Measures

Primary Outcomes (1)

• Change in Acylcarnitine/Carnitine ratio

  Baseline, One Month

Secondary Outcomes (3)

• Change in Protein acetylation

  Baseline, One Month

• Change in Insulin Sensitivity

  Baseline, One Month

• Change in Mitochondrial Function

  Baseline, One Month

Study Arms (1)

Acute Exercise

EXPERIMENTAL

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

Interventions

Acute Exercise OTHER

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

Acute Exercise

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Pfizer: collaborator

Study Sites (1)

Duke Center for Living

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Glucose Intolerance; Motor Activity; Insulin Resistance

Interventions

Exercise

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• William E Kraus, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: April 28, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 17, 2015

Record last verified: 2015-06

Locations

US (1)