Evaluation of Ubiquinol on Mitochondrial Oxidative Capacity in Statin Patients Using 31PMRS

This study is currently recruiting participants.
Verified October 2012 by Beth Israel Deaconess Medical Center
Sponsor:
Information provided by (Responsible Party):
Jim S Wu, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01702987
First received: October 5, 2012
Last updated: October 13, 2012
Last verified: October 2012
  Purpose

It is our primary hypothesis that statin drugs impair skeletal muscle mitochondrial function and that ubiquinol (the reduced active form of CoQ10) supplementation will block impairment of PCr recovery kinetics in patients using statins. The investigators propose a pilot study to extend our research to examine PCr recovery kinetics in 20 statin users randomized in a parallel arm study to either ubiquinol or placebo over 4 weeks.


Condition Intervention
Myopathy
HMG COA Reductase Inhibitor Adverse Reaction
Hypercholesterolemia
Dietary Supplement: ubiquinol
Dietary Supplement: placebo
Drug: statin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Evaluation of Ubiquinol on the Association of Statins and Mitochondrial Oxidative Capacity Using 31P Magnetic Resonance Imaging

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • phosphocreatine recovery [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Phosphocreatine recovery as measured by 31PMRS is the primary outcome measure is a representative of mitochondrial oxidative capacity


Estimated Enrollment: 20
Study Start Date: October 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Statin + placebo
10 patients taking statin medications and placebo.
Dietary Supplement: placebo
placebo (identical in appearance to ubiquinol)
Other Name: placebo
Drug: statin
Active Comparator: Statin + ubiquinol
10 patients on statins and ubiquinol
Dietary Supplement: ubiquinol
ubiquinol supplementation will be given for 1 month to 10 patients
Other Name: coenzyme Q10
Drug: statin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Persons age 18 years and older who have been advised to use a statin medication by their physician.
  2. Up to ten individuals will have a history of statin myalgia on observed statin rechallenge. All others will have a history (>6 months) of tolerating a statin at a standard starting dose or higher.
  3. All persons will be able to cooperate for a period of 1-2 hours, able to provided informed consent and have no known adverse effects or contraindications to an MRI study.

Exclusion Criteria:

  1. Having diabetes or known lower extremity peripheral vascular disease, as these conditions may interfere with interpretation of the MRI spectroscopy of the lower extremity (the only site we are examining in this study).
  2. Current users of a statin with a recent heart attack, stroke, or revascularization procedure (within the last 1 year) who could be at higher risk of stopping a statin.
  3. Creatine kinase (CK) > 5 x ULN. If CK levels are greater than 3 x ULN, the participant will be given the option of returning for a repeat blood draw at their earliest convenience. Any elevation in CK will be treated per the safety guidelines outlined in section B5.
  4. Alanine transferase (ALT) or aspartate transferase (AST) > 3 x ULN. If ALT and/or AST levels are greater than 3 x ULN, the participant will return for a repeat blood draw at their earliest convenience. If the participant's ALT and/or AST is found elevated at this repeat analysis, they will be withdrawn from the study. Any elevation in ALT and/or AST will be treated per the safety guidelines outlined in section B5.
  5. Severe uncontrolled medical problems or medications that may influence measurements or impair ability to participate in the study exams (e.g. poorly controlled hypertension; (>170/>100); known creatinine > 2.5 md/dl or GFR < 30; anemia with Hgb < 10, etc.).
  6. Pregnancy or breastfeeding (a contraindication for statin use)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01702987

Contacts
Contact: Jim S Wu, MD 617-667-1283 jswu@bidmc.harvard.edu
Contact: Catherine Buettner, MD cbuettne@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jim S Wu, MD    617-667-1283    jswu@bidmc.harvard.edu   
Contact: Allison Glasgow    617-66-70324    alglasgo@bidmc.harvard.edu   
Principal Investigator: Jim S Wu, MD         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Jim S Wu, MD Beth Israel Deaconess
  More Information

Publications:
Responsible Party: Jim S Wu, Assistant Professor Department of Radiology, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01702987     History of Changes
Other Study ID Numbers: 010-31415
Study First Received: October 5, 2012
Last Updated: October 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
ubiquinol (coenzyme Q10)

Additional relevant MeSH terms:
Muscular Diseases
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Coenzyme Q10
Ubiquinone
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Vitamins
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014