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

ISRCTN	ISRCTN89304265
DOI	https://doi.org/10.1186/ISRCTN89304265
Secondary identifying numbers	CZB/4/622

Submission date: 03/02/2011
Registration date: 03/05/2011
Last edited: 03/09/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Sandra MacRury
Scientific

Department of Diabetes and Cardiovascular Science
UHI Millennium Institute
Centre for Health Science
Old Perth Road
Inverness
IV2 3JH
United Kingdom

Phone	+44 (0)1463 279583
Email	sandra.macrury@uhi.ac.uk

Study information

Study design	Double-blind placebo-controlled randomised crossover study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	NAC study
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	12/01/2010
Completion date	25/08/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	22 (in each group)
Key inclusion criteria	1. Adult type-2 diabetes patients (men or post-menopausal women) 2. Either not receiving (group A) or receiving (group B) aspirin
Key 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
Date of first enrolment	12/01/2010
Date of final enrolment	25/08/2010

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

Department of Diabetes and Cardiovascular Science

Inverness
IV2 3JH
United Kingdom

Sponsor information

NHS Highland Health Board (United Kingdom)
Hospital/treatment centre

c/o Ms Frances Hines
NHS Highland
Research Office
The Centre for Health Science
Old Perth Road
Inverness
IV2 3JH
Scotland
United Kingdom

Phone	+44 (0)1463 255822
Email	frances.hines@nhs.net
"ROR"	https://ror.org/010ypq317

Funders

Funder type

Government

Chief Scientist Office (CSO) - Scottish Health Executive (United Kingdom)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2012		Yes	No