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

NCT01702987 | Completed Results

• 1 other identifier: 2012P000219
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myopathy; HMG COA Reductase Inhibitor Adverse Reaction; Hypercholesterolemia

Keywords

ubiquinol (coenzyme Q10)

Outcome Measures

Primary Outcomes (1)

• Phosphocreatine Recovery

  Percentage change in phosphocreatine recovery from baseline to month as measured by 31PMRS is the primary outcome measure is a representative of mitochondrial oxidative capacity

  1 month

Study Arms (2)

Statin + placebo

PLACEBO COMPARATOR

9 patients taking statin medications and placebo.

Dietary Supplement: placebo; Drug: statin

Statin + ubiquinol

ACTIVE COMPARATOR

12 patients on statins and ubiquinol

Dietary Supplement: ubiquinol; Drug: statin

Interventions

ubiquinol DIETARY_SUPPLEMENT

ubiquinol supplementation was given for 1 month to 12 patients

Also known as: coenzyme Q10

Statin + ubiquinol

placebo DIETARY_SUPPLEMENT

placebo (identical in appearance to ubiquinol) was given for 1 month to 9 patients

Statin + placebo

statin DRUG

statin was given for 1 month to 21 patients

Also known as: Simvastatin, Atorvastatin, Rosuvastatin

Statin + placebo; Statin + ubiquinol

Eligibility Criteria

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

You may qualify if:

• Persons age 18 years and older who have been advised to use a statin medication by their physician.
• 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.
• 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.

You may not qualify if:

• 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).
• 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.
• 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.
• 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.
• 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.).
• Pregnancy or breastfeeding (a contraindication for statin use)

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Wu JS, Buettner C, Smithline H, Ngo LH, Greenman RL. Evaluation of skeletal muscle during calf exercise by 31-phosphorus magnetic resonance spectroscopy in patients on statin medications. Muscle Nerve. 2011 Jan;43(1):76-81. doi: 10.1002/mus.21847.

  PMID: 21171098 BACKGROUND

MeSH Terms

Conditions

Muscular Diseases; Hypercholesterolemia

Interventions

ubiquinol; coenzyme Q10; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Simvastatin; Atorvastatin; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Sulfones; Sulfur Compounds; Pyrimidines

Results Point of Contact

• Title: Jim Wu
• Organization: Beth Israel Deaconess Medical Center

jswu@bidmc.harvard.edu

617-754-2390

Study Officials

• Jim S Wu, MD

  Beth Israel Deaconess

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Department of Radiology

Study Record Dates

• First Submitted: October 5, 2012
• First Posted: October 10, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: April 17, 2017
• Results First Posted: April 17, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)