Diabetes prevention in people from Bangladesh: a pilot trial in East London

ISRCTN	ISRCTN37781193
DOI	https://doi.org/10.1186/ISRCTN37781193
Clinical Trials Information System (CTIS)	2007-004283-47
Protocol serial number	N0624177960
Sponsor	Queen Mary, University of London (UK)
Funders	Medical Research Council (G0501284), UK Department of Health (DH) Excess Treatment Costs, North East London Consortium for Research and Development (NELCRAD) (UK) (funded the pre-pilot studies), NHS Research and Development Support Funding (UK) (funded the pre-pilot studies)

Submission date: 29/09/2006
Registration date: 29/09/2006
Last edited: 22/05/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
The number of people developing diabetes as adults is growing and in Europe is set to increase by at least 50% in the next 10 years. The problem is particularly intense in people of south Asian origin, where there is 3-6 times the prevalence of type 2 diabetes and the disease presents 10-15 years earlier compared to white Europeans. Based on research in the USA, Finland and India, it is possible to prevent diabetes with a programme of exercise and changes in diet, as well as use of a drug (metformin). The aim of this study is to determine the right methods to test whether this type of programme will be successful in preventing diabetes in people at high risk of the disease in an ethnic minority group, the Bangladeshi community.

Who can participate?
People of Bangladeshi origin aged 20-70 years at high risk of diabetes

What does the study involve?
Participants are randomly allocated to either the control group, who receive standard healthy lifestyle advice, or the behavioural lifestyle intervention group, who receive individual and group advice on diet, exercise and smoking cessation over six fortnightly sessions. Metformin is offered to all participants after 6 months.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Institute of Cell and Molecular Science (ICMS) (UK)

When is the study starting and how long is it expected to run for?
June 2005 to October 2012

Who is funding the study?
The Medical Research Council and the Department of Health (UK)

Who is the main contact?
Prof. Graham Hitman
g.a.hitman@qmul.ac.uk

Contact information

Prof Graham Hitman
Scientific

Diabetes & Metabolic Medicine
Institute of Cell and Molecular Science (ICMS)
4 Newark Street
Whitechapel
London
E1 2AT
United Kingdom

Phone	+44 (0)207 882 2356
Email	g.a.hitman@qmul.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Diabetes prevention in people from Bangladesh: a pilot trial in East London
Study acronym	BanglaDiP
Study objectives	Current study hypothesis as of 07/05/2013: To check the feasibility of key aspects of identification of high-risk individuals for diabetes by comparing recruitment using an adapted Cambridge Risk Score (CRS) or a direct screening process using a health examination. 200 high-risk subjects will be randomly allocated to a structured lifestyle intervention or usual care. At six months all participants will have the option to take metformin. The overall purpose is to generate pilot data that can be used to design a pragmatic and culturally sensitive RCT for diabetes prevention in the local Bangladeshi population. Study hypothesis amended as of 07/08/2007: To check the feasibility of key aspects of identification of high-risk individuals for diabetes by comparing recruitment using an adapted Cambridge Risk Score (CRS) or a direct screening process using a health examination. 200 high-risk subjects will be randomly allocated to a factorial design of structured lifestyle intervention and pharmacotherapy using metformin. The overall purpose is generate pilot data that can be used to design a pragmatic and culturally sensitive RCT for diabetes prevention in the local Bangladeshi population. Study hypothesis provided at time of registration: Will members of the Bangladeshi population allow recruitment to the testing the tools and be willing to undergo the lifestyle interventions to prevent diabetes?
Ethics approval(s)	1. Central Office of Research Ethics Committees (COREC), East London (ref: 05/Q0605/164), approval first granted on 19/01/2006, amendment 1 approved on 26/01/2007 2. New application to COREC South East and Medicines and Healthcare products Regulatory Agency (MHRA) for subsequent phases of the study approved 18/10/2007
Health condition(s) or problem(s) studied	Nutritional, Metabolic, Endocrine: Diabetes
Intervention	Current interventions as of 07/05/2013: Arm 1: Control Intervention (n=100); will be given standard healthy lifestyle advice. Arm 2: Behavioural Lifestyle Intervention based on a self-efficacy model (n=100); encompassing individual and group advice on diet, exercise and smoking cessation over six fortnightly sessions. Metformin 500 mg twice daily (bd) will be offered to all participants at 6 months. Previous interventions amended as of 07/08/2007: Arm 1: Control Intervention (n=50); will be given standard healthy lifestyle advice. Arm 2: Behavioural Lifestyle Intervention based on a self-efficacy model (n=50); encompassiing individual and group advice on diet, exercise and smoking cessation over six fortnightly sessions. Arm 3: Pharmacotherapy only (n=50); Metformin 500 mg twice daily (bd) will be given to participants as well as standard healthy lifestyle advice. Arm 4: Both behavioural and pharmacotherapy (n=50). Interventions provided at time of registration: Pilot RCT study. To assess recruitment methods and 'risk' data.
Intervention type	Mixed
Primary outcome measure(s)	Primary outcome measure as of 07/08/2007: In non-diabetic Bangladeshi participants to test the feasibility of key aspects of identification, recruitment methods, the screening process, interventions and measurement of outcomes for a culturally appropriate RCT to prevent diabetes and subsequent cardiovascular disease. Previous primary outcome measures: Cambridge risk score and Finnish score
Key secondary outcome measure(s)	Added as of 07/05/2013: 1. Ascertaining the quality of the datasets that can be used to determine risk held in primary care databases and what actions are required to ensure that they are complete 2. Designing, validating and establishing cut-off points for a disease susceptibility risk score to assess whether it is feasible to identify people with the metabolic syndrome in the Bangladeshi community 3. Proportion of eligible people consenting to randomisation (phase 3) and the adherence to or concordance with the intervention by those identified as having metabolic syndrome by direct testing (phase 1) compared to those identified as high risk from the CRS (phase 2) 4. From phase 1 the prevalence of metabolic syndrome, IGT and diabetes in the study population 5. Does venesection impair recruitment? 6. Training manual for lay tutors and a set of SOPs for a future trial 7. Adherence, acceptability and attendance of the behavioural lifestyle intervention 8. Adherence with the study drug in an otherwise well population 9. An approximate indication of changes and variability of possible outcome variables (fasting glucose, waist, weight, BP and conversion to diabetes) in the intervention group as a whole rather than by treatment group. 10. Development and translation of culturally appropriate questionnaires (GHQ12, SF12, modified diabetes IPQ-R and RPAQ) and the feasibility of their use individually and combined in the Bangladeshi community 11. The design of a culturally appropriate RCT of a multi-factorial intervention to prevent diabetes and subsequently cardiovascular disease in the local Bangladeshi community 12. Cost-effectiveness model informing cost data collection in the main trial 13. Judgement about the viability of the main trial with Bangladeshi participants from Tower Hamlets
Completion date	12/10/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	500
Key inclusion criteria	Current inclusion criteria as of 07/05/2013: For screening strategies, 500 people of Bangladeshi origin aged 20-70 years divided into two groups: 1. Dataset 1 will be invited to have an Oral Glucose Tolerance Test (OGTT) and fasting lipid profile and then if at high risk of diabetes invited to intervention 2. Dataset 2 will be identified as high risk from GP records and then invited directly for intervention Previous inclusion criteria: 500 subjects of Bangladeshi origin aged 20-65 years divided randomly into two groups, dataset 1 being invited to have an Oral Glucose Tolerance Test (OGTT) and fasting lipid profile.
Key exclusion criteria	Added as of 07/08/2007: 1. Outside age range 2. Major co-morbidity including cardiovascular disease, diabetes and cancer 3. Contra-indications to metformin
Date of first enrolment	01/06/2005
Date of final enrolment	12/10/2012

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Institute of Cell and Molecular Science (ICMS)

London
E1 2AT
United Kingdom

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

22/05/2017: No publications found, verifying study status with principal investigator.
07/05/2013: The overall trial end date was changed from 31/05/2010 to 12/10/2012.