Effect of Empagliflozin versus Metformin on weight and metabolic parameters in overweight patients treated with atypical antipsychotics

Effect of Empagliflozin versus Metformin on weight and metabolic parameters in overweight patients treated with atypical antipsychotics: a double-blind randomized clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120215009014N538

Enrollment

Registered

2024-11-12

Start date

2025-01-04

Completion date

Unknown

Last updated

2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Schizophrenia. Condition 2: Bipolar disorder. Schizophrenia Bipolar disorder

Interventions

Intervention 1: Intervention group: Empagliflozin tablets 10 mg once a day for 12 weeks. Intervention 2: Control group: Metformin tablets 1000 mg once a day for 12 weeks.

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Age 18 to 60 years Schizophrenia or bipolar disorder Body mass index above 27 Antipsychotic treatment for at least one month

Exclusion criteria

Exclusion criteria: Type 1 or 2 diabetes Alcohol or drug use Liver or kidney failure

Design outcomes

Primary

Measure	Time frame
Hemoglobin A1c. Timepoint: Before the intervention and 12 weeks later. Method of measurement: By taking a blood sample.;Fasting blood sugar. Timepoint: Before the intervention and 12 weeks later. Method of measurement: By taking a blood sample.;Average weight. Timepoint: Before intervention and 12 weeks later. Method of measurement: scales.;Mean body mass index. Timepoint: Before the intervention and 12 weeks later. Method of measurement: Body mass index = person's weight (kilograms) / height (meters) to the power of 2.;Serum insulin levels. Timepoint: Before the intervention and 12 weeks later. Method of measurement: By taking blood samples.;Lipid profile (triglyceride, cholesterol, LDL and HDL). Timepoint: Before the intervention and 12 weeks later. Method of measurement: By taking blood samples.	—

Measure

Time frame

Hemoglobin A1c. Timepoint: Before the intervention and 12 weeks later. Method of measurement: By taking a blood sample.;Fasting blood sugar. Timepoint: Before the intervention and 12 weeks later. Method of measurement: By taking a blood sample.;Average weight. Timepoint: Before intervention and 12 weeks later. Method of measurement: scales.;Mean body mass index. Timepoint: Before the intervention and 12 weeks later. Method of measurement: Body mass index = person's weight (kilograms) / height (meters) to the power of 2.;Serum insulin levels. Timepoint: Before the intervention and 12 weeks later. Method of measurement: By taking blood samples.;Lipid profile (triglyceride, cholesterol, LDL and HDL). Timepoint: Before the intervention and 12 weeks later. Method of measurement: By taking blood samples.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAtena Dolati

Hamedan University of Medical Sciences

d.atena2001@gmail.com+98 81 3838 0572

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026