We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2014 by University Hospitals, Leicester.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00318032
First Posted: April 25, 2006
Last Update Posted: July 2, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Department of Health, United Kingdom
Information provided by (Responsible Party):
University Hospitals, Leicester
  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: None (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

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 ]

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 ]
  • To assess the economic and psychological cost of screening [ Time Frame: At end of study ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Bodicoat DH, O'Donovan G, Dalton AM, Gray LJ, Yates T, Edwardson C, Hill S, Webb DR, Khunti K, Davies MJ, Jones AP. The association between neighbourhood greenspace and type 2 diabetes in a large cross-sectional study. BMJ Open. 2014 Dec 23;4(12):e006076. doi: 10.1136/bmjopen-2014-006076.
Mostafa SA, Davies MJ, Morris DH, Yates T, Srinivasan BT, Webb D, Brady E, Khunti K. The association of the triglyceride-to-HDL cholesterol ratio with insulin resistance in White European and South Asian men and women. PLoS One. 2012;7(12):e50931. doi: 10.1371/journal.pone.0050931. Epub 2012 Dec 10.
Mostafa SA, Khunti K, Kilpatrick ES, Webb D, Srinivasan BT, Gray LJ, Davies MJ. Diagnostic performance of using one- or two-HbA1c cut-point strategies to detect undiagnosed type 2 diabetes and impaired glucose regulation within a multi-ethnic population. Diab Vasc Dis Res. 2013 Jan;10(1):84-92. doi: 10.1177/1479164112451473. Epub 2012 Jul 6.
Mostafa SA, Davies MJ, Webb DR, Srinivasan BT, Gray LJ, Khunti K. Independent effect of ethnicity on glycemia in South Asians and white Europeans. Diabetes Care. 2012 Aug;35(8):1746-8. doi: 10.2337/dc11-2079. Epub 2012 Jun 14.
Gray LJ, Yates T, Davies MJ, Brady E, Webb DR, Sattar N, Khunti K. Defining obesity cut-off points for migrant South Asians. PLoS One. 2011;6(10):e26464. doi: 10.1371/journal.pone.0026464. Epub 2011 Oct 19.
Webb DR, Gray LJ, Khunti K, Srinivasan B, Taub N, Campbell S, Barnett J, Farooqi A, Echouffo-Tcheugui JB, Griffin SJ, Wareham NJ, Davies MJ. Screening for diabetes using an oral glucose tolerance test within a western multi-ethnic population identifies modifiable cardiovascular risk: the ADDITION-Leicester study. Diabetologia. 2011 Sep;54(9):2237-46. doi: 10.1007/s00125-011-2189-2. Epub 2011 Jun 3.
Webb DR, Khunti K, Srinivasan B, Gray LJ, Taub N, Campbell S, Barnett J, Henson J, Hiles S, Farooqi A, Griffin SJ, Wareham NJ, Davies MJ. Rationale and design of the ADDITION-Leicester study, a systematic screening programme and randomised controlled trial of multi-factorial cardiovascular risk intervention in people with type 2 diabetes mellitus detected by screening. Trials. 2010 Feb 19;11:16. doi: 10.1186/1745-6215-11-16.

Responsible Party: University Hospitals, Leicester
ClinicalTrials.gov Identifier: NCT00318032     History of Changes
Other Study ID Numbers: 9320
7254
First Submitted: January 23, 2006
First Posted: April 25, 2006
Last Update Posted: July 2, 2014
Last Verified: July 2014

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


To Top