Metformin Alleviates Abnormal Glucose Metabolism Induced by Statins in Schizophrenia Patients

NCT07045142 · tracked via the Priya Life Science China tracker

Sponsor

Central South University

Phase

Phase 3

Started

2025-07-01

Last updated

2026-08-03

Condition(s) studied

Schizophrenia

Investigational drug(s) / intervention(s)

Atorvastatin →Metformin →Placebo

Atorvastatin: Participants will receive atorvastatin 20 mg daily.

Metformin: Participants will receive metformin 1000 mg daily.

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

Study 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

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Inclusion criteria: 1. Aged between 18 and 65 years, regardless of gender, and meets the diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); 2. Symptoms and medication regimen stable for more than 3 months, with the allowance of up to two antipsychotic medications in combination (concurrent use of antidepressants, anxiolytics, and mood stabilizers is permitted); 3. Temporary use of benzodiazepines is allowed; 4. Meets at least one of the following conditions: fasting total cholesterol (TC) ≥ 5.2 mmol/L; fasting triglycerides (TG) ≥ 1.7 mmol/L; fasting low-density lipoprotein cholesterol (LDL-C) ≥ 3.4 mmol/L; 5. Two fasting blood glucose (FPG) tests must be \< 6.1 mmol/L (with an interval of 1-4 weeks); 6. It is anticipated that there will be no issues related to relocation, transportation difficulties, or access to medical care throughout the study; 7. Informed consent must be obtained from the patient and their guardian, and a consent form must be signed. Exclusion criteria: 1. Patients with a prior diagnosis of diabetes or complications such as diabetic ketoacidosis; 2. Patients with liver or kidney dysfunction, indicated by aspartate aminotransferase (AST), alanine aminotransferase (ALT), or gamma-glutamyl transferase (GGT) levels exceeding twice the normal limits, and/or creatinine levels exceeding 1.2 times the upper limit of the reference range or greater than 2 mg/dL, or deemed by the investigator to have liver and/or kidney impairment that warrants exclusion from the study; 3. Patients with severe gastrointestinal, respiratory, endocrine, hematologic diseases, or metabolic absorption disorders: including but not limited to poorly controlled diabetes, severe acute systemic infections or immunological diseases, ischemic heart disease, cerebrovascular accidents within the past year, history of prolonged QT interval, active hepatitis B virus, chronic active hepatitis C, and malabsorption syndromes; 4. Clinically significant abnormal ECG findings at screening that the investigator deems unsuitable for inclusion, such as male QTc interval \> 470 ms, female QTc interval \> 480 ms; 5. Pregnant or nursing women.

Primary outcome measure(s)

Change from Baseline in Fasting Blood Glucose Concentration — Baseline, 3rd month, 6th month
Change from Baseline in Glycated Hemoglobin (HbA1c) Concentration — Baseline, 3rd month, 6th month
Oral Glucose Tolerance Test — Baseline, 3rd month, 6th month
The Oral Glucose Tolerance Test (OGTT) requires subjects to undergo an 8-hour fasting period, followed by an initial measurement of fasting blood glucose via a portable glucometer using a finger prick. Subsequently, subjects are instructed to consume a solution containing 75 grams of anhydrous glucose dissolved in 300 milliliters of water. Blood samples are then collected through finger pricking at 1 hour and 2 hours post-ingestion for further analysis of glucose levels.

Trial sites (8)

Facility	City	Region	Status
Zhumadian Second People's Hospital	Zhumadian	Henan	Active Not Recruiting
Mental Health Institute of Second Xiangya Hospital, CSU	Changsha	Hunan	Recruiting
The Third Hospital of Changsha County	Changsha	Hunan	Active Not Recruiting
The Second People's Hospital of Xiangyin County	Yueyang	Hunan	Active Not Recruiting
Junshan District Psychiatric Rehabilitation Hospital	Yueyang	Hunan	Active Not Recruiting
Yueyang Rehabilitation Hospital	Yueyang	Hunan	Recruiting
The Second People's Hospital of Dali Bai Autonomous Prefecture	Dali	Yunnan	Completed
Xiangshan County Traditional Chinese Medicine Hospital Medical and Health Group Three Hospitals District	Xiangshan	Zhejiang	Active Not Recruiting

On this site

📄 Lipitor (atorvastatin) drug profile → 📄 Glucophage (metformin) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07045142 on ClinicalTrials.gov ↗ ← All trials in China