Empagliflozin, Metformin, or both for muscle energy in adults with type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, open-label interventional study enrolling 54 adults with newly diagnosed type 2 diabetes. Participants are assigned equally to receive empagliflozin alone, metformin alone, or both drugs together for evaluation of muscle oxidative capacity and microvascular function using near-infrared spectroscopy. Primary outcome is the change in skeletal muscle oxidative capacity at rest, measured in the non-dominant forearm muscle. The trial explores whether SGLT2 inhibition, metformin therapy, or their combination can favorably modify muscle energetics beyond glycemic effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male sex
* Age 18-75 years
* Newly diagnosed type 2 diabetes mellitus, confirmed no more than 2 years prior to enrollment
* Body mass index (BMI) 25-35 kg/m²
* Currently managed at a diabetes outpatient clinic
* No known chronic diabetes-related complications
* No prior antidiabetic pharmacological treatment, with the exception of sulfonylureas

Exclusion Criteria:

* Other forms of diabetes mellitus (i.e., not type 2)
* Type 2 diabetes mellitus known for more than 2 years
* Comorbidities known to independently affect skeletal muscle oxidative capacity, including: spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis, cystic fibrosis, local joint immobility, or hemiplegia
* Known mitochondrial disease
* Heart failure, NYHA class II or higher
* Chronic kidney disease, stage 3 or higher
* Poorly controlled chronic medical conditions (e.g., arterial hypertension, hypothyroidism)
* Recurrent urinary tract infections
* Active malignancy currently undergoing oncologic treatment
* Life expectancy less than 3 months
* Symptomatic hyperglycemia with fasting plasma glucose above 18 mmol/L, HbA1c ≥ 10%
* Unwillingness to provide informed consent

Where it's running

• UMC Ljubljana
  Ljubljana, Slovenia Recruiting

Study contacts

• Study coordinator: Eva Podbregar Kolar, MD
• Email: evapodbregar@gmail.com
• Phone: +38640762768

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.