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Metformin Alleviates Abnormal Glucose Metabolism Induced by Statins in Schizophrenia Patients

StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Secondary endpoints: 5 to 6v8
  2. Site details revised at 4 of 8 sitesv7
  3. Site details revised at 3 of 8 sitesv6
  4. Study sites: 6 to 8
    • Collaborators: 5 to 7
    v5
  5. Enrollment target: 200 to 400v4 Show 4 more changesShow less
    • Secondary endpoints: 7 to 5
    • Study sites revised (6)
    • Collaborators revised (5)
    • Publications: details revised at 4 of 4 entries
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 6 of 6 sites
    v3
  2. Primary endpoints revised (3)
    • Interventions: Atorvastatin with metformin treatment (Drug), atorvastatin with placebo treatment (Drug) to Atorvastatin (Drug), Metformin (Drug), Placebo (Drug)
    • Secondary endpoints revised (7)
    • Study title shortened, about 7 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)		 Schizophrenia
Related terms Dyslipidemias, Schizophrenia
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov