Clinical Trial

Metformin Alleviates Abnormal Glucose Metabolism Induced by Statins in Schizophrenia Patients

Recruiting Phase 3
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Summary
Schizophrenia is a severe mental illness associated with significant morbidity and disability. Patients often experience metabolic side effects from antipsychotic medications, including weight gain and dyslipidemia. Statins, commonly used to manage dyslipidemia, can lower cholesterol levels but may increase the risk of new-onset diabetes. This study aims to investigate how atorvastatin affects glucose metabolism in schizophrenia patients and assess whether metformin can help improve these metabolic issues. The investigators will include 200 patients with dyslipidemia from the Second Xiangya Hospital and other sites, randomly assigning them to receive either atorvastatin with metformin or atorvastatin with placebo over six months. Key goals include evaluating the impact of atorvastatin on insulin resistance and blood glucose levels and determining the effectiveness of metformin in mitigating glucose metabolism abnormalities while managing lipid levels. Understanding these interactions will help improve treatment strategies for schizophrenia patients, potentially lowering their risk of cardiovascular diseases and diabetes and enhancing overall health outcomes.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2025-06-22; most recent amendment 2026-06-01.
Status change: Not Yet Recruiting → Recruiting 2025-07-16
Trial Details
NCT Number NCT07045142
Lead Sponsor Central South University
Collaborators: Zhumadian Second People's Hospital, The Third Hospital of Changsha County, The Second People's Hospital of Dali Bai Autonomous Prefecture, Xiangshan County Traditional Chinese Medicine Hospital Medical and Health Group Three Hospitals Distric, Yueyang Rehabilitation Hospital, Junshan District Psychiatric Rehabilitation Hospital, The Second People's Hospital of Xiangyin County
Conditions Schizophrenia
Enrollment 400 participants
Start Date 2025-07-01
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-03