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Metabolic and Mitochondrial Changes in Statin-Induced Myopathy

NCT07511686 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 38

Last updated 2026-04-06

No results posted yet for this study

Summary

The goal of this observational study is to learn whether statin-related muscle symptoms are linked to problems in fat metabolism in muscle cells, specifically involving acylcarnitines, in adults taking or not taking statins. The main questions it aims to answer are:

Do patients with statin-associated muscle symptoms have higher acylcarnitine levels in blood and muscle compared to statin users without symptoms and people not taking statins? Do acylcarnitine levels decrease after stopping or reducing statin treatment in affected patients?

Researchers will compare patients with statin-associated muscle symptoms, statin users without symptoms, and individuals not taking statins to see if differences in acylcarnitine levels and muscle metabolism are associated with muscle symptoms.

Participants will:

Provide blood samples for biochemical tests and acylcarnitine analysis Share information about their health, medications, and lifestyle (Optional) undergo a muscle biopsy to study muscle metabolism Some participants with muscle symptoms will have repeat blood tests and possibly a repeat muscle biopsy after statin dose reduction or discontinuation to track changes over time

Conditions

  • Statin Adverse Reaction
  • Statin-induced Myopathy

Interventions

OTHER

Blood sampling and laboratory assessment

Collection of blood samples for measurement of acylcarnitine concentrations and routine biochemistry, including creatine kinase and lipid profile.

OTHER

Muscle biopsy

Optional muscle tissue sampling under local anesthesia from the non-dominant forearm muscle for assessment of acylcarnitine concentrations and mitochondrial fatty acid metabolism.

Sponsors & Collaborators

  • Latvian Institute of Organic Synthesis

    collaborator OTHER

  • University of Latvia

    collaborator OTHER

  • Riga Stradins University

    lead OTHER

Principal Investigators

  • Gustavs Latkovskis, PhD, MD · Faculty of Medicine, University of Latvia

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-22
Primary Completion
2024-10-09
Completion
2024-10-09
FDA Drug
Yes

Countries

  • Latvia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07511686 on ClinicalTrials.gov