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

Sponsor
The 95th Hospital of Putian，Putian, Fujian, China
Study ID
NCT07778719
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
30 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Metformin + Dapagliflozin — DRUG
    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 — DRUG
    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.

Study Details

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.

Key Dates

First listed
Aug 21, 2026
Start date
Oct 1, 2026
Status verified
Aug 2026
Primary completion
Oct 10, 2027
Completion
Dec 11, 2027

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Metformin groups
    Continue monotherapy with metformin (maintain the original dose).
  • Experimental: Metformin+ Dapagliflozin group
    Metformin (maintain the original dose) + Dapagliflozin 10 mg/day

Primary Outcome Measure

ΔIGF-1 [ Time Frame: 12 weeks ]

Central Contacts

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