Actively Recruiting
Metformin Alleviates Abnormal Glucose Metabolism Induced by Statins in Schizophrenia Patients
Led by Central South University · Updated on 2026-03-17
400
Participants Needed
8
Research Sites
152 weeks
Total Duration
On this page
Sponsors
C
Central South University
Lead Sponsor
Z
Zhumadian Second People's Hospital
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Metformin Alleviates Abnormal Glucose Metabolism Induced by Statins in Schizophrenia Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 65 years, with any gender, and diagnosed with schizophrenia based on DSM-5 criteria
- Symptoms and medication regimen stable for over 3 months, allowing up to two antipsychotic medications and use of antidepressants, anxiolytics, mood stabilizers, and temporary benzodiazepines
- Meets at least one lipid criterion: fasting total cholesterol ≥ 5.2 mmol/L; fasting triglycerides ≥ 1.7 mmol/L; or fasting LDL cholesterol ≥ 3.4 mmol/L
- Two fasting blood glucose tests below 6.1 mmol/L, taken 1 to 4 weeks apart
- No expected issues with relocation, transportation, or access to medical care throughout the study
- Signed informed consent obtained from patient and guardian
You will not qualify if you...
- Prior diagnosis of diabetes or diabetes-related complications such as diabetic ketoacidosis
- Liver or kidney dysfunction indicated by abnormal liver enzymes or creatinine levels exceeding specified thresholds, or investigator judgment of impairment
- Severe gastrointestinal, respiratory, endocrine, blood, or metabolic absorption disorders, including poorly controlled diabetes, severe infections, ischemic heart disease, recent cerebrovascular accident, prolonged QT interval history, active hepatitis B or C, or malabsorption syndromes
- Clinically significant abnormal ECG results unsuitable for inclusion, such as QTc interval > 470 ms for males or > 480 ms for females
- Pregnant or nursing women
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Zhumadian Second People's Hospital
Zhumadian, Henan, China
Actively Recruiting
2
Mental Health Institute of Second Xiangya Hospital, CSU
Changsha, Hunan, China
Actively Recruiting
3
The Third Hospital of Changsha County
Changsha, Hunan, China
Actively Recruiting
4
The Second People's Hospital of Xiangyin County
Yueyang, Hunan, China, 410500
Actively Recruiting
5
Junshan District Psychiatric Rehabilitation Hospital
Yueyang, Hunan, China, 414000
Actively Recruiting
6
Yueyang Rehabilitation Hospital
Yueyang, Hunan, China, 414022
Actively Recruiting
7
The Second People's Hospital of Dali Bai Autonomous Prefecture
Dali, Yunnan, China
Actively Recruiting
8
Xiangshan County Traditional Chinese Medicine Hospital Medical and Health Group Three Hospitals District
Xiangshan, Zhejiang, China, 315799
Actively Recruiting
Research Team
J
Jing Huang
CONTACT
X
Xinyi Zhao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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