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Recruiting Phase 4

The Effect of Empagliflozin and Metformin on Oxidative Capacity and Microvascular Reactivity of Skeletal Muscle in Patients With Type 2 Diabetes Mellitus

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About this study

The purpose of the study is to compare the effect of empagliflozin, metformin, and the combination of both on the oxidative capacity of skeletal muscle and its microvascular reactivity in individuals with newly diagnosed type 2 diabetes. As the primary outcome, the investigators selected the change in skeletal muscle oxidative capacity and posed the following scientific question: Does empagliflozin significantly improve the oxidative capacity of skeletal muscle? The study will enroll 54 individuals with type 2 diabetes in a prospective, randomized, interventional, open-label study. Participants will be randomized into 3 equally sized groups: 1) a group receiving empagliflozin; 2) a group receiving metformin; and 3) a group receiving a combination of both drugs (empagliflozin and metformin). The investigators will analyze the clinical variables of the subjects, near-infrared spectroscopy (NIRS) measurements over the flexor digitorum superficialis muscle of the non-dominant arm at rest, after submaximal muscular work, and during transient brachial artery occlusion at specified time intervals (14 days, 1 month, 3 months, 6 months), as well as body composition, physical performance, and glycemic control following the pharmacological intervention.

Condition
Diabetes Type 2
Tested
Empagliflozin (Jardiance®), Metformin, Synjardy® 12.5mg/1000mg film-coated tablets
Sponsor
University Medical Centre Ljubljana

Who can join

Age
18 to 75 years
Sex
Male only
Healthy volunteers
Not accepted

Inclusion 11

  • Minimum age: 18 years
  • Maximum age: 75 years
  • Eligible sex: Male
  • Study condition: Diabetes Type 2
  • 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 12

  • 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

1 site, 1 recruiting

UMC Ljubljana

Ljubljana, Slovenia

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.