Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-28 @ 12:04 AM
Study NCT ID:
NCT00850460
Status:
TERMINATED
Last Update Posted:
2016-11-07
First Post:
2009-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Quality of Life in Patients With Statin-Associated Myopathy
Sponsor:
Rockefeller University
Organization:
Study Overview
Official Title:
Quality of Life and Metabolic Alterations in Patients With Statin-Associated Myopathy
Status:
TERMINATED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Investigator left institution and no PI has been found to continue the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The proposed study will focus on possible effects of statins on muscle strength and why they become tired more easily, quality of life, and measurements to understand why muscles are not able to fully utilize fats. The investigators are specifically interested in statin users and the impact of muscle symptoms on daily activities and quality of life.
This study hypothesize that patients with likely statin-associated myopathy have a metabolic dysregulation in fuel utilization such that compared to patients continuing statins, those on placebo will show:
1. improved Individualized Neuromuscular Quality of Life (INQoL) and Short Form-36 (SF-36) scores (primary end point)
2. alleviation of muscle symptoms,
3. increased utilization of fatty acids as a fuel source reflected by the metabolic test results
4. decreased intramyocellular lipid (IMCL)
5. improved insulin sensitivity.
This study hypothesize that patients with likely statin-associated myopathy have a metabolic dysregulation in fuel utilization such that compared to patients continuing statins, those on placebo will show:
1. improved Individualized Neuromuscular Quality of Life (INQoL) and Short Form-36 (SF-36) scores (primary end point)
2. alleviation of muscle symptoms,
3. increased utilization of fatty acids as a fuel source reflected by the metabolic test results
4. decreased intramyocellular lipid (IMCL)
5. improved insulin sensitivity.
Detailed Description:
The proposed study will focus on possible effects of statins on muscle strength and quality of life, and measurements to understand why muscles of statin users are not able to fully utilize fats. The investigators are specifically interested in statin users and the impact of muscle symptoms on daily activities and quality of life.
This study hypothesizes that patients with likely statin-associated myopathy have a metabolic dysregulation in fuel utilization such that compared to patients continuing statins, those on placebo will show:
1. improved INQoL and SF-36 scores (primary end point)
2. alleviation of muscle symptoms,
3. increased utilization of fatty acids as a fuel source reflected by the metabolic test results
4. decreased IMCL
5. improved insulin sensitivity.
This study hypothesizes that patients with likely statin-associated myopathy have a metabolic dysregulation in fuel utilization such that compared to patients continuing statins, those on placebo will show:
1. improved INQoL and SF-36 scores (primary end point)
2. alleviation of muscle symptoms,
3. increased utilization of fatty acids as a fuel source reflected by the metabolic test results
4. decreased IMCL
5. improved insulin sensitivity.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: