SGLT-2 Inhibition and Cardiovascular Disease. Metabolomics Study of Potential Factors Involved in Cardioprotection

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina Y Salud (FIMABIS)0 个研究点目标入组 60 人开始时间: 2018年10月25日最近更新: 2019年2月28日

适应症

试验速览

暂无简介。

•- Age 18-75.
•- BMI 27-39.9 kg/m2.
•- T2DM under treatment with metformin and inadequate metabolic control (defined as HbA1c=6.5% and =7%).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 60
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 60

•- Pregnancy (all women of child-bearing age, unless treatment with contraceptive methods, will undergo a pregnancy test)
•- Intolerance/allergy to dapagliflozin.
•- Treatment with antidiabetic drug other than metformin.
•- Impaired kidney function: Estimated glomerular filtration rate (eGFR) (calculated using the CKD-EPI formula) <60 ml/min/1.73m2.
•- 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 levels three times higher than normal upper limit.
•- Known HIV infection or active HBV or HCV infection.
•- Serious underlying diseases, which could affect the patient's ability to participate in the study.
•- Reduced life expectancy (<12 months) due to the presence of advanced or terminal concomitant diseases.

发起方

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina Y Salud (FIMABIS)