Contact information
Type
Scientific
Primary contact
Prof Sandra MacRury
ORCID ID
Contact details
Department of Diabetes and Cardiovascular Science
UHI Millennium Institute
Centre for Health Science
Old Perth Road
Inverness
IV2 3JH
United Kingdom
+44 (0)1463 279583
sandra.macrury@uhi.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CZB/4/622
Study information
Scientific title
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
Acronym
NAC study
Study hypothesis
Oral NAC has efficacy in preventing hyperactivity of platelets in type 2 diabetes, either as an adjunct to existing therapy or as an independent anti-thrombotic agent available to patients contraindicated for aspirin.
Ethics approval
North of Scotland Research Ethics Service, ref no: 06/S0901/39, Approval granted : 27th Nov 2006. AM01 Dec 2006, AM02 Nov 07, AM03 17/03/09, AM04 (minor) 08/06/09
Study design
Double-blind placebo-controlled randomised crossover study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Type 2 Diabetes
Intervention
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 activity and fibrinolytic potential in patients with type 2 diabetes who are either not receiving (Group A) or are receiving (Group B) aspirin
2. After 1 week on either placebo or NAC, patients will 'cross over' to the alternative treatment arm following a 1 week wash out period. Thus, trial medication will be taken for 2 weeks per patient (1 week on NAC, the other on placebo) over a total period of 3 weeks. The total timeframe of the study is envisaged to be less than 1 year from the start date.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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 outcome measures
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
Overall trial start date
12/01/2010
Overall trial end date
25/08/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Adult type-2 diabetes patients (men or post-menopausal women)
2. Either not receiving (group A) or receiving (group B) aspirin
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
22 (in each group)
Participant 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
Recruitment start date
12/01/2010
Recruitment end date
25/08/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Diabetes and Cardiovascular Science
Inverness
IV2 3JH
United Kingdom
Sponsor information
Organisation
NHS Highland Health Board (United Kingdom)
Sponsor details
c/o Ms Frances Hines
NHS Highland
Research Office
The Centre for Health Science
Old Perth Road
Inverness
IV2 3JH
United Kingdom
+44 (0)1463 255822
frances.hines@nhs.net
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Chief Scientist Office (CSO) - Scottish Health Executive (United Kingdom)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22935960
Publication citations
-
Results
Treweeke AT, Winterburn TJ, Mackenzie I, Barrett F, Barr C, Rushworth GF, Dransfield I, MacRury SM, Megson IL, N-Acetylcysteine inhibits platelet-monocyte conjugation in patients with type 2 diabetes with depleted intraplatelet glutathione: a randomised controlled trial., Diabetologia, 2012, 55, 11, 2920-2928, doi: 10.1007/s00125-012-2685-z.