Condition category
Circulatory System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
11/12/2008
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

Dr Daniel Flanagan

ORCID ID

Contact details

Royal Bournemouth & Christchurch NHS Trust
Bournemouth Diabetes and Endocrine Centre
Castle Lane East
Bournemouth
BH7 7DW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RS/06/07.98/Fl

Study information

Scientific title

Acronym

Study hypothesis

The consumption of modest amounts of alcohol, on a regular basis, appears to reduce the risk of developing cardiovascular disease. The aim of this study was to determine whether alcohol exhibits this protection through a reduction in insulin resistance.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Cardiovascular diseases: Heart disease

Intervention

1. 3 units of alcohol in the form of vodka daily for 7 days
2. No alcohol

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Fasting glucose, insulin, insulin sensitivity or glucose effectiveness, first phase insulin secretion

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/02/1999

Overall trial end date

31/01/2000

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/02/1999

Recruitment end date

31/01/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Bournemouth & Christchurch NHS Trust
Bournemouth
BH7 7DW
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive South West (UK)

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

2002 results in http://www.ncbi.nlm.nih.gov/pubmed/11895470

Publication citations

  1. Results

    Flanagan DE, Pratt E, Murphy J, Vaile JC, Petley GW, Godsland IF, Kerr D, Alcohol consumption alters insulin secretion and cardiac autonomic activity., Eur. J. Clin. Invest., 2002, 32, 3, 187-192.

Additional files

Editorial Notes