Glutathione status in platelets from patients with Type 2 Diabetes: therapeutic potential of N-Acetylcysteine (NAC) to help prevent platelet hyperaggregability
ISRCTN | ISRCTN89304265 |
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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
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 |
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sandra.macrury@uhi.ac.uk |
Study information
Study design | Double-blind placebo-controlled randomised crossover study |
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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 |
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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
IV2 3JH
United Kingdom
Sponsor information
NHS Highland Health Board (United Kingdom)
Hospital/treatment centre
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 |
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frances.hines@nhs.net | |
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 | |
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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? |
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Results article | results | 01/11/2012 | Yes | No |