Effect of Aspirin on renal disease progression in patients with type 2 diabetes: a multicentre double-blind, placebo-controlled, randomised trial. The LEDA (renaL disEase progression by aspirin in Diabetic pAtients) study - Aspirin and renal function in type 2 diabetes

MBERTO I - POLICLINICO DI ROMA0 个研究点目标入组 418 人开始时间: 2020年11月4日最近更新: 2021年8月2日

适应症

试验速览

暂无简介。

•-Age =35 years
•- Diagnosis of type 2 diabetes:
•-random blood glucose = 200 mg / dl (=11.1 mmol/l)
•-fasting blood glucose = 126 mg/dl (=7.0 mmol/l). Fasting is defined as no caloric intake for at least 8 h.*
•-blood glucose 2 hours after oral glucose tolerance test (75 g OGTT) =200 mg/dl. The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water.*
•-hemoglobin A1c = 6.5% (= 48 mmol/mol). The test should be performed in a laboratory using a method that is NGSP certified and standardized to the DCCT assay.*
•-treatment with any glucose-lowering agent.
•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 209
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 209

•1) History of cardiovascular or cerebrovascular events (defined on history and/or instrumental findings provided by the patient);
•2) Presence of inadequate glycemic control (i.e., hemoglobin A1c =8%)
•3) Presence of uncontrolled blood pressure despite anti-hypertensive treatment (=140/=85 mmHg)
•4) Previous major bleeding (i.e. intracranial)
•5) Previous gastro-intestinal ulcer
•6) Clinical diagnosis of type 1 diabetes (diagnosis of diabetes and insulin use before 35 years of age);
•7) Patients with chronic kidney disease G4 or G5 stage (i.e., eGFR <30 ml/min/1.73 m2 or dialysis);
•8) Chronic active infections or
•9) Evidence of malignancy in the last 5 years. Patients with in situ neoplastic disease successful treated only with local excision can be included in the study (including in situ non-melanoma skin cancer).
•10) Autoimmune systemic diseases;
•11) Sustained cardiac arrhythmias requiring anticoagulant treatment (i.e. atrial fibrillation). In this category isolated ventricular/supraventricular extra-systoles are not included;
•12) Use of non-steroidal anti-inflammatory drugs, or other antiplatelet agents in the previous 30 days;
•13) Cirrhosis of any etiology
•14) Use of anticoagulants;
•15) Life expectancy <1 year;
•16) Known allergy to aspirin;
•17) Known pregnancy;
•18) Severe psychiatric illness.

发起方

MBERTO I - POLICLINICO DI ROMA