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

NCT02124590

Last updated date
Study Location
Duke Center for Living
Durham, North Carolina, 27710, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Elderly, Pre-diabetic
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
60-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Elderly, Pre-diabeticThe Effect of Oral Carnitine Supplementation on MRS-derived Mitochondrial Function
NCT02124590
  1. Durham, North Carolina
ALL GENDERS
60 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE The Effect of Oral Carnitine Supplementation on MRS-derived Mitochondrial Function
Official Title  ICMJE The Effect of Oral Carnitine Supplementation on MRS-derived Mitochondrial Function
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Elderly
  • Pre-diabetic
Intervention  ICMJE
  • Other: Acute Exercise
    Repeated isometric leg exercises at varying intensities for up to twelve minutes per bout. Leg exercises will target the quadriceps muscles.
  • Other: Acute Exercise
    Aerobic exercise session on a bike at 50% of peak VO2 for 30 minutes.
Study Arms  ICMJE Experimental: Acute Exercise
Repeated isometric leg exercises at varying intensities and a second visit with aerobic bike exercise for 30 minutes at 50% peak VO2.
Interventions:
  • Other: Acute Exercise
  • Other: Acute Exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 15, 2015)
14
Original Estimated Enrollment  ICMJE
 (submitted: April 24, 2014)
10
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 60 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02124590
Other Study ID Numbers  ICMJE Pro00053117
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:William E Kraus, MDDuke University
PRS Account Duke University
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP