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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list