Trial record 7 of 155 for:
Open Studies | "Hydroxymethylglutaryl-CoA Reductase Inhibitors"
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:
Beth Israel Deaconess Medical Center
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
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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:
- 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.
Exclusion Criteria:
- 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)
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:
|
Hypercholesterolemia Muscular Diseases 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 May 21, 2013