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

ISRCTN	ISRCTN80995714
DOI	https://doi.org/10.1186/ISRCTN80995714
Protocol serial number	WE1
Sponsor	Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Funder	NHS Cardiovascular Disease and Stroke National Research and Development Programme

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration.
Completion date	01/07/1997

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

United Kingdom
Ireland

Study participating centre

Conway Institute

Dublin
4
Ireland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Editorial Notes

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