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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003122-27-IT

Enrollment

Registered

2012-03-13

Start date

2011-11-01

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 1 diabetes MedDRA version: 14.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: CARDIOASPIRIN*30CPR GAST 100MG Pharmaceutical Form: Gastro-resistant tablet Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100-

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Italy

Contacts

Public ContactSERVIZIO DI DIABETOLOGIA

POLICLINICO GEMELLI

dario.pitocco@rm.unicatt.it0630154217

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026