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

ConditionsType 2 DiabetesMetabolic Dysfunction-Associated Steatotic Liver Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age30-60
SponsorThe 95th Hospital of Putian，Putian, Fujian, China

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Males aged 30-60 years;

Meeting the WHO diagnostic criteria for type 2 diabetes mellitus, with HbA1c levels between 7.0% and 10.0%;

Having received a stable dose of metformin (≥1500 mg/day or the maximum tolerated dose) as monotherapy for at least 8 weeks;

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;

Disqualifiers

Type 1 diabetes mellitus or other specific types of diabetes;

Weekly alcohol intake exceeding 210g for males;

Concomitant chronic liver diseases (viral hepatitis, autoimmune liver disease, Wilson's disease, hemochromatosis, etc.);

Known pituitary or hypothalamic diseases affecting the GH-IGF-1 axis;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: Metformin groupsActive comparator 1 intervention
Group B: Metformin+ Dapagliflozin groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ΔIGF-1

The difference in the change value of serum IGF-1 levels (ΔIGF-1) from baseline to 3 months between the two groups.

Time frame
12 weeks
2

Changes in non-invasive indicators of liver fibrosis

Differences in the change values of the FIB-4 index from baseline to 3 months between the two groups

Time frame
12 weeks

Secondary outcomes

1

Changes in liver fat content

Differences in the change value of CAP (ΔCAP) from baseline to 3 months between the two groups

Time frame
12 weeks
2

Changes in non-invasive indicators of liver fibrosis

Differences in the change values of LSM from baseline to 3 months between the two groups

Time frame
12 weeks
3

ΔIGF-1/IGFBP3 molar ratio

Differences in changes in the IGF-1/IGFBP3 molar ratio between the two groups

Time frame
12 weeks
4

Changes in glucose metabolism indicators

Differences in HbA1c between the two groups

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: