Diabetes risk from statins in schizophrenia: could metformin be the answer?
NCT ID NCT07045142
First seen Jun 24, 2026 · Last updated Aug 04, 2026 · Updated 5 times
Summary
This study tests whether the diabetes drug metformin can prevent blood sugar increases caused by statins in people with schizophrenia. Researchers will give 400 patients either metformin or a placebo alongside atorvastatin for six months. The goal is to see if metformin helps keep glucose levels stable, reducing the risk of diabetes and heart disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Metformin
- What this could lead to
- If it works, this could offer a way to prevent diabetes in schizophrenia patients who need statins for heart health, improving their overall care.
- What could go wrong
- This is a phase 3 trial, but it's still early to know if metformin will work for this specific use. The study focuses on blood sugar markers, not long-term health outcomes, and metformin may cause digestive side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Junshan District Psychiatric Rehabilitation Hospital
ACTIVE_NOT_RECRUITINGYueyang, Hunan, 414000, China
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Mental Health Institute of Second Xiangya Hospital, CSU
RECRUITINGChangsha, Hunan, China
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The Second People's Hospital of Dali Bai Autonomous Prefecture
COMPLETEDDali, Yunnan, China
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The Second People's Hospital of Xiangyin County
ACTIVE_NOT_RECRUITINGYueyang, Hunan, 410500, China
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The Third Hospital of Changsha County
ACTIVE_NOT_RECRUITINGChangsha, Hunan, China
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Xiangshan County Traditional Chinese Medicine Hospital Medical and Health Group Three Hospitals District
ACTIVE_NOT_RECRUITINGXiangshan, Zhejiang, 315799, China
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Yueyang Rehabilitation Hospital
RECRUITINGYueyang, Hunan, 414022, China
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Zhumadian Second People's Hospital
ACTIVE_NOT_RECRUITINGZhumadian, Henan, China
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