Condition category
Nutritional, Metabolic, Endocrine
Date applied
03/02/2011
Date assigned
03/05/2011
Last edited
03/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 ƒÝmol 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

  1. 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.

Additional files

Editorial Notes