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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Department of Health, United Kingdom
Information provided by (Responsible Party):
University Hospitals, Leicester
ClinicalTrials.gov Identifier:
NCT00318032
First received: January 23, 2006
Last updated: July 1, 2014
Last verified: July 2014
  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
Type 2 Diabetes Mellitus
Drug: multi-factorial intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
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 [ Time Frame: At end of study ] [ Designated as safety issue: No ]

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 [ Time Frame: At end of study ] [ Designated as safety issue: No ]
  • To assess the economic and psychological cost of screening [ Time Frame: At end of study ] [ Designated as safety issue: No ]

Enrollment: 8579
Study Start Date: August 2004
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Intensive Treatment
Frequent specialised diabetes clinician contact. DESMOND self-management programme
Drug: multi-factorial intervention

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00318032

Locations
United Kingdom
University Hospitals of Leicester, Leicester Royal Infirmary
Leicester, Leicestershire, United Kingdom, LE4 0AW
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):

Responsible Party: University Hospitals, Leicester
ClinicalTrials.gov Identifier: NCT00318032     History of Changes
Other Study ID Numbers: 9320, 7254
Study First Received: January 23, 2006
Last Updated: July 1, 2014
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 July 31, 2014