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RECRUITING
NCT07045142
PHASE3

Metformin Alleviates Abnormal Glucose Metabolism Induced by Statins in Schizophrenia Patients

Sponsor: Central South University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2025-07-01

Completion Date

2028-06-01

Last Updated

2026-03-17

Healthy Volunteers

No

Conditions

Interventions

DRUG

Atorvastatin

Participants will receive atorvastatin 20 mg daily.

DRUG

Metformin

Participants will receive metformin 1000 mg daily.

DRUG

Placebo

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