Condition category
Circulatory System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
06/12/2013
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 Paul McKeigue

ORCID ID

Contact details

Conway Institute
University College Dublin
Belfield
Dublin
4
Ireland
+353 1 716 6952

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

WE1

Study information

Scientific title

Acronym

Study hypothesis

People from South Asia have a 40% higher incidence of coronary heart disease, and a fivefold higher rate of non-insulin-dependant diabetes compared to other UK residents. These problems are linked to metabolic disturbances associated with insulin resistance and central obesity.
The aims of this study were to see if these metabolic disturbances could be reversed by exercise or by dietary supplementation with omega-3 fatty acids.

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

Heart disease

Intervention

There were three exercise categories
i. Walking
ii. Jogging
iii. Running
comprising a 12 week programme with examinations 24 hours after the last session; a similar programme with examinations 5 days after the last session; and no change in activity. The exercise programmes involved three half hour sessions of walking/jogging/running, and one supervised aerobic circuit session per week.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Insulin resistance was measured by a frequently-sampled intravenous glucose tolerance test after a 3-day high carbohydrate diet.
2. Cardio-respiratory function was assessed by measuring oxygen uptake during exercise on a treadmill using the Bruce protocol.
3. Before the programme height, weight, hip and waist circumference were measured. Information was sought on medical history, and on cigarette and alcohol consumption.

Secondary outcome measures

Not provided at time of registration.

Overall trial start date

01/07/1994

Overall trial end date

01/07/1997

Reason abandoned

Eligibility

Participant inclusion criteria

92 subjects were recruited from general practices in West London. 87 subjects completed the trial made up of 28 South Asian men, 12 South Asian women, 27 European men, and 20 European women.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

87

Participant exclusion criteria

Not provided at time of registration.

Recruitment start date

01/07/1994

Recruitment end date

01/07/1997

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Conway Institute
Dublin
4
Ireland

Sponsor information

Organisation

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Cardiovascular Disease and Stroke National Research and Development Programme

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

Publication citations

Additional files

Editorial Notes