SGLT-2 Inhibition, Metabolomics and Cardiovascular/Kidney Disease

Exclusion Criteria

• •Pregnancy (all women of child-bearing age, unless on treatment with contraceptive methods, will undergo a pregnancy test)
• •Breastfeeding
• •Intolerance/allergy to dapagliflozin.
• •Treatment with antidiabetic drug other than metformin.
• •Impaired kidney function: Estimated glomerular filtration rate (eGFR) \<60 ml/min/1.73m2 (calculated using the CKD-EPI formula).
• •Patients with established cardiovascular disease.
• •Previous or current history of cancer of any kind.
• •Uncontrolled hypertension (systolic blood pressure≥160 mmHg or diastolic blood pressure≥110 mmHg, despite adequate antihypertensive treatment).
• •History of liver tumour or acute or chronic liver disease with impaired liver function: total bilirubin levels\> 2.0 mg / dl or GOT/GPT levels three times higher than normal upper limit.
• •Known HIV infection or active HBV or HCV infection.
• •Other serious underlying diseases, which could affect the patient's ability to participate in the study.
• •Reduced life expectancy (\<12 months) due to advanced or terminal concomitant diseases.
• •In addition, female patients of child-bearing age will be advised to use contraceptive methods during the study period, given the contraindication of dapagliflozin and metformin during pregnancy as per normal clinical practice.