Aspirin and renal function in type 2 diabetes
- Conditions
- Type 2 diabetesMedDRA version: 20.0Level: LLTClassification code 10012594Term: DiabetesSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2015-005231-40-IT
- Lead Sponsor
- MBERTO I - POLICLINICO DI ROMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 418
-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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the relationship between progression of renal failure and aspirin use in patients suffering from type 2 diabetes;Secondary Objective: To evaluate the relationship between urinary excretion of thromboxane B2 and changes in renal function;Primary end point(s): The aim of our study is to evaluate the decline of renal function in diabetic patients treated with aspirin 100 mg/day vs. placebo. In particular, we will evaluate:<br>- The absolute change in eGFR, calculated as the difference between eGFR at 12 months - baseline eGFR;<br>- The rapid decline in renal function, defined as a reduction of eGFR =5 ml/min at 1 years. <br>- The change of renal function class (from G1 to G2, from G2 to G3a and so on) at 6 and 12 months.;Timepoint(s) of evaluation of this end point: 6 months and 1 year
- Secondary Outcome Measures
Name Time Method Secondary end point(s): As secondary endpoint, we will evaluate changes in the urinary excretion TxB2 both baseline and at one year. Changing levels of urinary TxB2 will then be related to renal function.;Timepoint(s) of evaluation of this end point: 6 months and 1 year