Metformin Alleviates Abnormal Glucose Metabolism Induced by Statins in Schizophrenia Patients

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.

Conditions

• Schizophrenia

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.

Sponsors & Collaborators

• Zhumadian Second People's Hospital

  collaborator UNKNOWN

• The Third Hospital of Changsha County

  collaborator UNKNOWN

• The Second People's Hospital of Dali Bai Autonomous Prefecture

  collaborator UNKNOWN

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

  collaborator UNKNOWN

• Yueyang Rehabilitation Hospital

  collaborator UNKNOWN

• Junshan District Psychiatric Rehabilitation Hospital

  collaborator UNKNOWN

• The Second People's Hospital of Xiangyin County

  collaborator UNKNOWN

• Central South University

  lead OTHER

Principal Investigators

• Renrong Wu · Mental Health Institute of Second Xiangya Hospital,CSU

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-01

Primary Completion

2027-12-31

Completion

2028-06-01

Countries

• China

Study Locations