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Comparative Effectiveness of Dapagliflozin, Metformin, and Lifestyle Modification for Antipsychotic-Induced Weight Gain: An Open-Label Pragmatic Trial
Sponsor: Sultan Qaboos University
Summary
Clinical trial: The goal of this clinical trial is to learn if dapagliflozin can help reduce weight gain caused by antipsychotic medications in people with schizophrenia and related disorders. It will also assess the safety of dapagliflozin. * The main questions it aims to answer are: * Does dapagliflozin lower body weight compared to metformin or lifestyle changes alone? * Does it improve blood sugar, cholesterol, and overall health? * Researchers will compare three groups: * Dapagliflozin plus lifestyle changes * Metformin plus lifestyle changes * Lifestyle changes alone * Participants will: * Take the assigned medication daily for 26 weeks (or follow lifestyle guidance only) * Attend clinic visits at weeks 0, 4, 12, and 26 for measurements and blood tests * Receive phone calls for follow-up and side effect checks
Official title: A Three-Arm Open-Label Pragmatic Trial Comparing Dapagliflozin, Metformin, and Lifestyle Modification for Antipsychotic-Induced Weight Gain
Key Details
Gender
All
Age Range
16 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-04
Completion Date
2028-12
Last Updated
2026-01-15
Healthy Volunteers
No
Conditions
Interventions
Metformin (1000 mg Twice a day)
Metformin tablets starting at 500 mg twice daily and increased to 1000 mg twice daily as tolerated, taken with meals for 26 weeks.
Dapagliflozin 10 mg
Dapagliflozin 10 mg tablet taken once daily for 26 weeks. It increases glucose excretion through urine and may lower weight.
Lifestyle Modification Program
Participants receive a structured lifestyle program, including dietary counseling, physical-activity planning, and behavioral support at scheduled visits (weeks 0, 4, 12, and 26).
Locations (1)
SQU
Muscat, Oman