A Study to Investigate the Benefits of the Early Detection and Intensive Treatment of Type 2 Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by University Hospitals, Leicester.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Department of Health, United Kingdom
Information provided by:
University Hospitals, Leicester
ClinicalTrials.gov Identifier:
NCT00318032
First received: January 23, 2006
Last updated: September 15, 2006
Last verified: September 2006
  Purpose

Diabetes is a common chronic condition associated with the risk of heart disease, and eye and kidney damage. Many people are diagnosed with diabetes when they develop symptoms or complications, suggesting that the true onset of disease occurs years earlier. Early detection of diabetes may result in health benefits, but this is not proven. People of South Asian origin are at more risk of having diabetes and of getting the heart disease complications associated with it. The study aims to test whether screening for diabetes is feasible in a South Asian population and to measure the benefits of early detection and intensive treatment.

Hypothesis: A program of screening and an intensive multi-factorial intervention for type 2 diabetes is both feasible and cost effective within primary care.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: multi-factorial intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Official Title: A Randomised Trial of the Cost Effectiveness of Screening and Intensive Multi-Factorial Intervention for Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by University Hospitals, Leicester:

Primary Outcome Measures:
  • To contribute to the ADDITION-Europe study, to assess screening and intensive treatment on 5 year cardiovascular outcomes

Secondary Outcome Measures:
  • To assess the feasibility of screening in a South Asian population and the effect of intensive treatment in people with screen detected diabetes on modelled cardiovascular risk at 1 year
  • To assess the economic and psychological cost of screening

Estimated Enrollment: 14500
Study Start Date: August 2004
Estimated Study Completion Date: January 2011
Detailed Description:

Although diabetes is commonly undiagnosed and many patients have evidence of complications at diagnosis, there is no definitive evidence that early detection improves health outcomes. One of the critical but uncertain factors is the extent to which screening and subsequent treatment reduces cardiovascular risk. Multi-factorial cardiovascular risk reduction in people with prevalent diabetes and microalbuminuria results in a halving of heart disease risk. However, it is not certain whether this result can be generalised to patients without microalbuminuria or those whose disease is screen-detected.

The ADDITION study is a collaborative randomised controlled trial of a target-driven intensive multi-factorial approach to cardiovascular risk reduction in patients with screen-detected type 2 diabetes mellitus, aimed at assessing the feasibility of screening in a primary care setting and quantifying the cardiovascular benefits and economic and psychological costs of screening. The study as a whole will have the power to determine whether screening and the intensive multi-factorial intervention results in improved cardiovascular outcomes. The ADDITON-Leicester study will contribute to this collaboration, but which by itself will demonstrate the feasibility of screening and measure the effect of the ADDITION study intervention on modelled cardiovascular risk at 1 year after detection by screening in a population at high risk by virtue of having a high proportion of people from South Asia (Leicester). The study is also assessing the impact of intensive intervention of modelled cardiovascular risk at 1 year.

People of South Asian origin are at increased risk of having diabetes and of developing heart disease. The issues of screening are thus particularly relevant to this population. However, all of the populations currently recruited to ADDITION are predominantly Caucasian. The ADDITION-Leicester study will assess the feasibility of systematic screening in a South Asian population, will quantify the effect of intensive treatment in people with screen detected diabetes on modelled cardiovascular risk at 1 year and will assess the economic and psychological costs of screening and intensive treatment. This study population will then contribute to the ADDITION-Europe study, which as a whole is powered to assess the impact of screening and intensive treatment on 5 year cardiovascular outcomes.

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patients who will be included into the study will be from the following groups:

  • White European subjects aged between 40-75 years
  • Asian, Black, or Chinese subjects aged between 25-75 years

Exclusion Criteria:

Patients will be excluded from the study if they:

  • Are housebound
  • Have a terminal illness
  • Have diabetes mellitus
  • Have an active psychotic illness which deems them unable to give informed consent.
  • Are pregnant or lactating
  • Are taking part in any other clinical trials
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00318032

Contacts
Contact: Melanie J Davies, MD +44 0116 2586798 melanie.davies@uhl-tr.nhs.uk
Contact: Emma L Healey, PhD +44 0116 2586798 emma.healey@uhl-tr.nhs.uk

Locations
United Kingdom
University Hospitals of Leicester, Leicester Royal Infirmary Recruiting
Leicester, Leicestershire, United Kingdom, LE4 0AW
Contact: Emma L Healey, PhD    +44 0116 2586798    emma.healey@uhl-tr.nhs.uk   
Contact: Jayne Hill    +44 0116 2586798    Jayne.Hill@uhl-tr.nhs.uk   
Principal Investigator: Melanie J Davies, MD         
Sponsors and Collaborators
University Hospitals, Leicester
Department of Health, United Kingdom
Investigators
Principal Investigator: Melanie J Davies, MD University Hospitals, Leicester
  More Information

No publications provided by University Hospitals, Leicester

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00318032     History of Changes
Other Study ID Numbers: 9320, 7254
Study First Received: January 23, 2006
Last Updated: September 15, 2006
Health Authority: United Kingdom: National Health Service

Keywords provided by University Hospitals, Leicester:
Randomised control trial
Screening
Intensive management
Diabetes mellitus
Type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014