Condition category
Nutritional, Metabolic, Endocrine
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
02/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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. From research in the USA, Finland and India, we know it is possible to prevent diabetes with a programme of exercise and changes in diet, as well as use of a drug (metformin). We propose a research study 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 will be randomly allocated to either the control group, who will receive standard healthy lifestyle advice, or the behavioural lifestyle intervention group, who will receive individual and group advice on diet, exercise and smoking cessation over six fortnightly sessions. Metformin will be offered to all participants at six months.

What are the possible benefits and risks of participating?
Not provided.

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?
The study will run from 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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Graham Hitman

ORCID ID

Contact details

Diabetes & Metabolic Medicine
Institute of Cell and Molecular Science (ICMS)
4 Newark Street
Whitechapel
London
E1 2AT
United Kingdom
+44 (0)207 882 2356
g.a.hitman@qmul.ac.uk

Additional identifiers

EudraCT number

2007-004283-47

ClinicalTrials.gov number

Protocol/serial number

N0624177960

Study information

Scientific title

Acronym

BanglaDiP

Study hypothesis

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?

On 07/05/2013 the anticipated end date was changed from 31/05/2010 to 12/10/2012.

Ethics approval

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

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 six 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

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

01/06/2005

Overall trial end date

12/10/2012

Reason abandoned

Eligibility

Participant 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, dataset 1 being invited to have an Oral Glucose Tolerance Test (OGTT) and fasting lipid profile and then if at high risk of diabetes invited to intervention. 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Target number of participants for intervention as of 07/08/2007: 200; Target number of participants for screening provided at time of registration: 500

Participant 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

Recruitment start date

01/06/2005

Recruitment end date

12/10/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Diabetes & Metabolic Medicine
London
E1 2AT
United Kingdom

Sponsor information

Organisation

Queen Mary, University of London (UK)

Sponsor details

Mile End Road
London
E1 4NS
United Kingdom

Sponsor type

University/education

Website

http://www.qmul.ac.uk/

Funders

Funder type

Government

Funder name

UK Medical Research Council (G0501284)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

UK Department of Health (DH) Excess Treatment Costs

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

North East London Consortium for Research and Development (NELCRAD) (UK) (funded the pre-pilot studies)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS Research and Development Support Funding (UK) (funded the pre-pilot studies)

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes