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

Completed

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

Registration Number: ISRCTN89304265

Lead Sponsor: HS Highland Health Board (United Kingdom)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 44

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>1.1. Degree of platelet activation using flow cytometry and platelet aggregometry ex vivo <br>1.2. Plasma tissue plasminogen activator (t-PA) expression and activity <br>1.3. Plasminogen activator inhibitor (PAI-1) expression and activity measured at baseline, Day 7, 15 and 21

Secondary Outcome Measures

Name	Time	Method
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<br>2. To establish whether fibrinolysis is also affected by oral dosing with NAC in patients with type 2 diabetes