Assessment of aspirin response in patients with Type 1 diabetes mellitus: a pilot study

Conditions: type 1 diabetes
MedDRA version: 14.1Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2011-003122-27-IT

Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Forty subjects with type 1 diabetes mellitus (30 treated and 10 untreated), male and female, 18-40 years old, BMI: 18-25 Kg/m2 .
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Cigarette smoking; - Allergy or intolerance to aspirin; - Other antiplatelet or anticoagulant treatment; - Presence of congenital bleeding coagulopathy; - Presence of macro/microangiopathy; - Any other known clinical comorbidity (eg celiac disease, hypothyroidism, hepatitis); -Pregnancy or breast feeding; - Any medication, except insulin; -Patients requiring regular use of nonsteroidal antiinflammatory drugs; -Hypertension; -Dyslipidemia; -Type 2 diabetes mellitus.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Assess whether, in patients with type 1 diabetes, changes in the rate of recovery of platelet COX-1 during and after treatment with aspirin at low doses, given at a dose of 100 mg (Cardioaspirin) as a single daily administration, are influenced by the variability of blood glucose in 24 hours.;Secondary Objective: Relationship between glycemic variability and platelet activation;Primary end point(s): kinetics of recovery of serum TxB2 formation in the range between 12h and 7 days after the last dose of aspirin (Cardioaspirin,100 mg).;Timepoint(s) of evaluation of this end point: 18 days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): correlation between kinetics of recovery of TxB2 formation in 24 h, blood glucose variability (using different indices) and average blood glucose, and platelet morphological indices in the routine blood count.;Timepoint(s) of evaluation of this end point: 18 days