NCT07778719Not yet recruiting
Metformin-Dapagliflozin Effects on IGF-1 in Male T2DM With MASLD
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
Source: ClinicalTrials.gov · Last updated 21 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- First submitted
- 13 Aug 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 10 Oct 2027
- Lead sponsor
- The 95th Hospital of Putian，Putian, Fujian, China
- NCT number
- NCT07778719
What you commit to
- Study type: Interventional
- Planned participants: 84
- From 1 Oct 2026 to the primary completion date, 10 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant chronic liver diseases (viral hepatitis, autoimmune liver disease, Wilson's disease, hemochromatosis, etc.);
- Previous or current use of GH preparations or IGF-1 preparations;
- Previous diagnosis of cardiovascular diseases (coronary heart disease, stroke, heart failure) or severe liver diseases (decompensated cirrhosis);
- Use of medications affecting IGF-1 levels (such as oral estrogens, high-dose glucocorticoids) within the past 3 months;
- Diabetic ketoacidosis, severe infection, or surgical stress within 1 month prior to enrollment.
Other illness
- Type 1 diabetes mellitus or other specific types of diabetes;
- Known pituitary or hypothalamic diseases affecting the GH-IGF-1 axis;
- Active malignant tumors;
- Allergy to dapagliflozin or similar drugs;
Lab values
- Baseline estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73m²;
Other
- Weekly alcohol intake exceeding 210g for males;
Who the study is looking for
- 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;
- No prior use of SGLT2 inhibitors, insulin secretagogues, insulin, or GLP-1 receptor agonists;
- Willing to participate voluntarily and sign the informed consent form.
Age in the registry: 30 years to 60 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Ethics Committee of Putian 95 Hospital Coordinator of this site? Confirm its status | Putian | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.