null - FindTrial

Glutathione Status in Platelets From Patients With Type 2 Diabetes: Therapeutic Potential of N-acetylcysteine to Help Prevent Platelet Hyperaggregability - NAC study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-001620-31-GB

Enrollment

Registered

2009-08-21

Start date

2009-09-14

Completion date

Unknown

Last updated

2012-07-24

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

Conditions

Platelet Aggregation in type 2 diabetes

Interventions

Product Name: acetylcysteine Pharmaceutical Form: Capsule, hard Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Men or post menopausal women with type 2 diabetes Not recieving aspirin (group A) Receiving Aspirin (Group B) 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Very poorly controlled diabetes (HbA1c > 10%) Significant hypertriglyceridaemia (TG > 4 mmol/L) Renal disease (creatinine > 150 umol/L) Current or recently stopped smokers (< 6 months) Patients receiving other anti platelet therapy (i.e. clopidogrel, dipyridamole), or lipid lowering therapy where the patients are unable or unwilling to stop therapy for the duration of study participation. Patients with asthma Current use of tetracycline antibiotics or cough suppressants

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the clinical potential of NAC in reducing thrombotic potential in patients with type 2 diabetes, either alone or as an adjunct to aspirin therapy.;Secondary Objective: To determine whether NAC orally has the same impact on platelet biochemistry and activity as found in the previous in vitro study. To establish whether fibrinolysis is also affected by oral dosing with NAC in patients with type 2 diabetes.;Primary end point(s): Does daily administration of NAC alone or as an adjunct to aspirin therapy for a period of 1 week alter platelet activation, as assessed by platelet-monocyte interaction and ex vivo platelet aggregometry? Does oral dosing with NAC alter platelet GCL activity, GSH levels and anti oxidant capacity? Does NAC alone or as an adjunct to aspirin therapy, alter plasma t-PA and/or PAI-1 levels?	—

Measure

Time frame

Main Objective: To determine the clinical potential of NAC in reducing thrombotic potential in patients with type 2 diabetes, either alone or as an adjunct to aspirin therapy.;Secondary Objective: To determine whether NAC orally has the same impact on platelet biochemistry and activity as found in the previous in vitro study. To establish whether fibrinolysis is also affected by oral dosing with NAC in patients with type 2 diabetes.;Primary end point(s): Does daily administration of NAC alone or as an adjunct to aspirin therapy for a period of 1 week alter platelet activation, as assessed by platelet-monocyte interaction and ex vivo platelet aggregometry? Does oral dosing with NAC alter platelet GCL activity, GSH levels and anti oxidant capacity? Does NAC alone or as an adjunct to aspirin therapy, alter plasma t-PA and/or PAI-1 levels?

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Countries

United Kingdom

Outcome results

None listed

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