Metformin efficacy in metabolic syndrome; dapagliflozin in metabolic syndrome

Comparison of dapagliflozin and metformin efficacy on metabolic syndrome induced by atypical antipsychotic drugs in patients with psychotic disorders: single blind randomized clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250712066463N1

Enrollment

Registered

2025-07-28

Start date

2025-07-21

Completion date

Unknown

Last updated

2025-08-19

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

Conditions

Condition 1: metabolic syndrome. Condition 2: bipolar disorder with psychotic feature. Metabolic syndrome Bipolar disorder, current episode depressed, severe, with psychotic features

Interventions

Intervention 1: Intervention group: Half of the patients were randomly receive 10 mg of dapagliflozin, a sodium glucose cotransporter (Actover Company, brand name Gludap)

once daily

regardless of meals. In the literature, this class has been shown to be more effective than other interventions in reducing metabolic syndrome factors. Intervention 2: Control group: According to the

the other half of the patients receive 1000 mg of slow-release metformin, owned by Anusha Pharmaceutical Company and the brand "Zoger", orally once a day with food.

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: psychotic disorder diagnosed by DSM-5 criteria minimum treatment duration with atypical antipsychotic(olanzapin an clozapin) 6 month stable weight body mass index >=25

Exclusion criteria

Exclusion criteria: pregnancy and lactation liver dysfunction as elevated transaminase more than 3 times renal dysfunction as creatinine clearance less than 45 diabetes mellitus type 1 and 2 cardiovascular disease or uncontrolled hypertention Corticosteroids treatment except levothyroxine weight lowering medicine in past 3 month

Design outcomes

Primary

Measure	Time frame
Systolic and diastolic blood perssure. Timepoint: week number 1-4-8-12. Method of measurement: Sphygmomanometer.;Fasting blood sugar. Timepoint: week number 1 and 12. Method of measurement: lab data.;Waist circumference. Timepoint: week 1-4-8-12. Method of measurement: meter -cm.;Triglyceride level. Timepoint: week number 1 and 12. Method of measurement: laboratory data.;Body mass index. Timepoint: week 1-4-8-12. Method of measurement: body weight/(height)2.;High density lipoprotein level. Timepoint: week 1-12. Method of measurement: laboratory data.	—

Measure

Time frame

Systolic and diastolic blood perssure. Timepoint: week number 1-4-8-12. Method of measurement: Sphygmomanometer.;Fasting blood sugar. Timepoint: week number 1 and 12. Method of measurement: lab data.;Waist circumference. Timepoint: week 1-4-8-12. Method of measurement: meter -cm.;Triglyceride level. Timepoint: week number 1 and 12. Method of measurement: laboratory data.;Body mass index. Timepoint: week 1-4-8-12. Method of measurement: body weight/(height)2.;High density lipoprotein level. Timepoint: week 1-12. Method of measurement: laboratory data.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSimin Khamoushi Abasi

Babol University of Medical Sciences

Simin.khamoushi@gmail.com+98 11 3220 0819

Outcome results

None listed

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