Glutathione status in platelets from patients with Type 2 Diabetes: therapeutic potential of N-Acetylcysteine (NAC) to help prevent platelet hyperaggregability

Glutathione status in platelets from patients with Type 2 Diabetes: therapeutic potential of N-Acetylcysteine (NAC) to help prevent platelet hyperaggregability, a double-blind placebo-controlled randomized crossover study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN89304265

Enrollment

Registered

2011-05-03

Start date

2010-01-12

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Type 2 Diabetes Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus

Interventions

1. This is a double-blind, placebo-controlled randomised crossover study to investigate the impact of oral dosing (1200 mg/day) with the anti-oxidant N-acetylcysteine (NAC) for 1 week on platelet acti

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult type-2 diabetes patients (men or post-menopausal women) 2. Either not receiving (group A) or receiving (group B) aspirin

Exclusion criteria

Exclusion criteria: 1. Glycated haemoglobin (HbA1c) greater than 10% 2. Random triglyceride greater than 4 mmol L-1 3. Creatinine > 150 ?Ýmol L-1 4. Current or recently stopped (less than 6 months) smoking 5. Receiving other antiplatelet therapy or lipid lowering therapy 6. Asthma sufferer 7. Current use of tetracycline or cough suppressants

Design outcomes

Primary

Measure	Time frame
1. Determine the clinical potential of NAC as an anti-thrombotic agent in patients with type-2 diabetes, either alone or as an adjunct to aspirin therapy 1.1. Degree of platelet activation using flow cytometry and platelet aggregometry ex vivo 1.2. Plasma tissue plasminogen activator (t-PA) expression and activity 1.3. Plasminogen activator inhibitor (PAI-1) expression and activity measured at baseline, Day 7, 15 and 21	—

Measure

Time frame

1. Determine the clinical potential of NAC as an anti-thrombotic agent in patients with type-2 diabetes, either alone or as an adjunct to aspirin therapy 1.1. Degree of platelet activation using flow cytometry and platelet aggregometry ex vivo 1.2. Plasma tissue plasminogen activator (t-PA) expression and activity 1.3. Plasminogen activator inhibitor (PAI-1) expression and activity measured at baseline, Day 7, 15 and 21

—

Secondary

Measure	Time frame
1. To determine whether oral dosing with NAC has the same impact on platelet biochemistry and activity, as found with the study in vitro, described above 2. To establish whether fibrinolysis is also affected by oral dosing with NAC in patients with type 2 diabetes	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 25, 2026