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Metformin-Dapagliflozin Effects on IGF-1 in Male T2DM With MASLD

Not Yet RecruitingNA

Sponsor: The 95th Hospital of Putian，Putian, Fujian, China

Conditions: Type 2 Diabetes, Metabolic Dysfunction-Associated Steatotic Liver Disease

Interventions: Metformin + Dapagliflozin, Metformin

Countries: China

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.

Eligibility overview

Sex: MALE

Age: 30 Years to 60 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Males aged 30-60 years;
2. Meeting the WHO diagnostic criteria for type 2 diabetes mellitus, with HbA1c levels between 7.0% and 10.0%;
3. Having received a stable dose of metformin (≥1500 mg/day or the maximum tolerated dose) as monotherapy for at least 8 weeks;
4. Meeting the diagnostic criteria for MASLD: Controlled Attenuation Parameter (CAP) value ≥248 dB/m detected, with the presence of at least one cardiometabolic risk factor;
5. No prior use of SGLT2 inhibitors, insulin secretagogues, insulin, or GLP-1 receptor agonists;
6. Willing to participate voluntarily and sign the informed consent form.

Exclusion Criteria:

1. Type 1 diabetes mellitus or other specific types of diabetes;
2. Weekly alcohol intake exceeding 210g for males;
3. Concomitant chronic liver diseases (viral hepatitis, autoimmune liver disease, Wilson's disease, hemochromatosis, etc.);
4. Known pituitary or hypothalamic diseases affecting the GH-IGF-1 axis;
5. Previous or current use of GH preparations or IGF-1 preparations;
6. Baseline estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73m²;
7. Previous diagnosis of cardiovascular diseases (coronary heart disease, stroke, heart failure) or severe liver diseases (decompensated cirrhosis);
8. Active malignant tumors;
9. Allergy to dapagliflozin or similar drugs;
10. Use of medications affecting IGF-1 levels (such as oral estrogens, high-dose glucocorticoids) within the past 3 months;
11. Diabetic ketoacidosis, severe infection, or surgical stress within 1 month prior to enrollment.

Locations (1)

Putian, Fujian, China