RecruitingPhase 3NCT07045142

Metformin Alleviates Abnormal Glucose Metabolism Induced by Statins in Schizophrenia Patients

Metformin Alleviates Abnormal Glucose Metabolism Induced by Statins in Schizophrenia Patients: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Study


Sponsor

Central South University

Enrollment

400 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether the diabetes drug metformin can prevent or reverse high blood sugar (a common side effect) caused by cholesterol-lowering statin medications in people with schizophrenia who are on stable psychiatric treatment. **You may be eligible if...** - You are between 18 and 65 years old with a schizophrenia diagnosis - Your psychiatric symptoms and medication have been stable for more than 3 months - You have elevated cholesterol or triglyceride levels that require statins - Your fasting blood sugar is currently normal (below diabetic range) **You may NOT be eligible if...** - You already have diabetes or have had diabetic complications - You have significant liver or kidney problems - You have certain heart conditions or had a recent stroke - You are pregnant or nursing - You have severe gastrointestinal or other serious medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAtorvastatin

Participants will receive atorvastatin 20 mg daily.

DRUGMetformin

Participants will receive metformin 1000 mg daily.

DRUGPlacebo

Participants will receive placebo 1000 mg daily, mimicking the appearance of metformin without containing active ingredients.


Locations(8)

Zhumadian Second People's Hospital

Zhumadian, Henan, China

Mental Health Institute of Second Xiangya Hospital, CSU

Changsha, Hunan, China

The Third Hospital of Changsha County

Changsha, Hunan, China

The Second People's Hospital of Xiangyin County

Yueyang, Hunan, China

Junshan District Psychiatric Rehabilitation Hospital

Yueyang, Hunan, China

Yueyang Rehabilitation Hospital

Yueyang, Hunan, China

The Second People's Hospital of Dali Bai Autonomous Prefecture

Dali, Yunnan, China

Xiangshan County Traditional Chinese Medicine Hospital Medical and Health Group Three Hospitals District

Xiangshan, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT07045142


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