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Metformin-Dapagliflozin Effects on IGF-1 in Male T2DM With MASLD
Sponsor: The 95th Hospital of Putian，Putian, Fujian, China
Summary
This is a 3-month, single-center, prospective, randomized, parallel-controlled, open-label trial investigating the effects of metformin combined with dapagliflozin on serum IGF-1 levels in male patients with type 2 diabetes mellitus (T2DM) and metabolic dysfunction-associated steatotic liver disease (MASLD). A total of 84 eligible male patients (aged 30-60 years, HbA1c 7.0%-10.0%, CAP ≥248 dB/m, on stable metformin monotherapy for ≥8 weeks) will be randomized 1:1 to either continue metformin alone or receive metformin plus dapagliflozin 10 mg/day for 12 weeks. The primary endpoint is the change in serum IGF-1 from baseline to 3 months between groups. Secondary endpoints include changes in hepatic steatosis (CAP), liver stiffness (LSM), FIB-4 index, metabolic parameters, and safety outcomes. The study aims to determine whether adding dapagliflozin to metformin can restore the suppressed GH-IGF-1 axis and provide mechanistic insights into its hepatoprotective effects.
Official title: Effects of Metformin Combined With Dapagliflozin on Serum IGF-1 Levels in Male Patients With Type 2 Diabetes Mellitus and Metabolic Dysfunction-Associated Steatotic Liver Disease
Key Details
Gender
MALE
Age Range
30 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
84
Start Date
2026-10-01
Completion Date
2027-12-11
Last Updated
2026-08-21
Healthy Volunteers
No
Interventions
Metformin + Dapagliflozin
Maintain the stable pre-enrollment dose of metformin (≥1500 mg/day or maximum tolerated dose) plus dapagliflozin 10 mg/day orally, administered once daily before breakfast, for 3 consecutive months. Other concomitant medications (e.g., antihypertensives, lipid-lowering agents) for both groups should remain unchanged during the study period unless clinically necessary adjustments are required. Patients should be instructed to maintain stable dietary and exercise habits throughout the study.
Metformin
Maintain the stable pre-enrollment dose of metformin monotherapy (≥1500 mg/day or maximum tolerated dose) for 3 consecutive months. Other concomitant medications (e.g., antihypertensives, lipid-lowering agents) for both groups should remain unchanged during the study period unless clinically necessary adjustments are required. Patients should be instructed to maintain stable dietary and exercise habits throughout the study.
Locations (1)
The Ethics Committee of Putian 95 Hospital
Putian, Fujian, China