Metformin Alleviates Abnormal Glucose Metabolism Induced by Statins in Schizophrenia Patients
Recruiting · NCT07045142 · Interventional (participants receive a specific treatment) · Lead sponsor: Central South University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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);
- 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);
- Temporary use of benzodiazepines is allowed;
- 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;
- Two fasting blood glucose (FPG) tests must be \< 6.1 mmol/L (with an interval of 1-4 weeks);
- It is anticipated that there will be no issues related to relocation, transportation difficulties, or access to medical care throughout the study;
- Informed consent must be obtained from the patient and their guardian, and a consent form must be signed.
Exclusion criteria
- Patients with a prior diagnosis of diabetes or complications such as diabetic ketoacidosis;
- 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;
- 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;
- 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;
- Pregnant or nursing women.
Where it is running
8 locations listed.
- 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