Development of interventions to reduce the risk of coronary heart disease (CHD) in South Asians

ISRCTN ISRCTN80995714
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

Conway Institute
University College Dublin
Belfield
Dublin
4
Ireland

Phone +353 (0)1 716 6952
Email abc@email.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific titleDevelopment of interventions to reduce the risk of coronary heart disease (CHD) in South Asians
Study objectivesPeople 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) studiedHeart disease
InterventionThere 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 typeOther
Primary outcome measure1. 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 measuresNot provided at time of registration.
Overall study start date01/07/1994
Completion date01/07/1997

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants87
Key inclusion criteria92 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 criteriaNot provided at time of registration.
Date of first enrolment01/07/1994
Date of final enrolment01/07/1997

Locations

Countries of recruitment

  • Ireland
  • United Kingdom

Study participating centre

Conway Institute
Dublin
4
Ireland

Sponsor information

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

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

Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Cardiovascular Disease and Stroke National Research and Development Programme

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

24/10/2019: No publications found. Verifying results with principal investigator.