Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-29 @ 4:58 PM
Study NCT ID:
NCT01040650
Status:
TERMINATED
Last Update Posted:
2013-08-30
First Post:
2009-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolic Features of Post-Myopathy Patients Associated With Statin Treatment
Sponsor:
Rockefeller University
Organization:
Study Overview
Official Title:
Metabolic Features of Post-Myopathy Patients Associated With Statin Treatment
Status:
TERMINATED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Principal Investigator left institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Statins are a class of drugs given to lower cholesterol. Although statins are considered to be generally safe, some studies show that about 10% of people on statins develop muscle-related symptoms, from fatigue (tiredness), weakness, cramping, pain and sometimes a lifethreatening muscle breakdown condition known as rhabdomyolysis. In some, these symptoms may greatly affect their daily activities. One consideration why symptoms develop in only some patients is that they may have an underlying problem in the way their muscles use fats to produce energy. In these patients, the muscles are not able to fully utilize fats and so they become tired more easily. Fat within the muscle can also affect how your body uses a hormone called insulin, which affects your blood sugar levels. The investigators are specifically interested in previous statin users and determine if the muscle symptoms are related to changes in energy and sugar use. We propose to enroll patients who have developed muscle side effects on previous statin treatment and have since discontinued statin treatment.
Our aim is to compare the metabolic parameters in these patients to age and gender-matched normal individuals.
Our aim is to compare the metabolic parameters in these patients to age and gender-matched normal individuals.
Detailed Description:
None
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?: