Metformin Alleviates Abnormal Glucose Metabolism Induced by Statins in Schizophrenia Patients

Launched by CENTRAL SOUTH UNIVERSITY · Jun 22, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how a medicine called metformin might help people with schizophrenia who are taking statins, a type of drug used to lower cholesterol. Statins can sometimes cause problems with blood sugar, which can lead to diabetes. This study wants to see if metformin can prevent these blood sugar problems while still helping to manage cholesterol levels. Researchers will work with about 200 patients who have both schizophrenia and high cholesterol or triglycerides. Participants will take atorvastatin (a statin) along with either metformin or a placebo (a pill with no active medicine) for six months.

To join the study, patients need to be adults aged 18 to 65 with a confirmed diagnosis of schizophrenia and stable symptoms for at least three months. They should have cholesterol or triglyceride levels above certain limits but normal blood sugar levels. People with diabetes, serious liver or kidney problems, or other major health issues won’t be able to participate. If accepted, participants will have regular check-ups to monitor their blood sugar, cholesterol, and overall health. This study could help find better ways to protect heart and metabolic health in people with schizophrenia.

Gender

ALL

Eligibility criteria

• 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.