Development of interventions to reduce the risk of coronary heart disease (CHD) in South Asians
ISRCTN | ISRCTN80995714 |
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DOI | https://doi.org/10.1186/ISRCTN80995714 |
Secondary identifying numbers | WE1 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 24/10/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Paul McKeigue
Scientific
Scientific
Conway Institute
University College Dublin
Belfield
Dublin
4
Ireland
Phone | +353 (0)1 716 6952 |
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abc@email.com |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Scientific title | Development of interventions to reduce the risk of coronary heart disease (CHD) in South Asians |
Study objectives | 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(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | 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 |
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 study start date | 01/07/1994 |
Completion date | 01/07/1997 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 87 |
Key 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. |
Key exclusion criteria | Not provided at time of registration. |
Date of first enrolment | 01/07/1994 |
Date of final enrolment | 01/07/1997 |
Locations
Countries of recruitment
- Ireland
- United Kingdom
Study participating centre
Conway Institute
Dublin
4
Ireland
4
Ireland
Sponsor information
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Website | http://www.doh.gov.uk |
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Funders
Funder type
Government
NHS Cardiovascular Disease and Stroke National Research and Development Programme
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 |
Editorial Notes
24/10/2019: No publications found. Verifying results with principal investigator.