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The ADDITION Study. Intensive Treatment in People With Screen Detected Diabetes in Primary Care. (ADDTION)

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.
ClinicalTrials.gov Identifier: NCT00237549
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : December 20, 2013
Steno Diabetes Centre, Gentofte, Denmark
University of Cambridge
University Hospitals, Leicester
Utrecht University
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

The ADDITION study comprise 2 parts: screening for Type 2 diabetes and intensive treatment compared to standard treatment.

  1. In the screening study, the feasibility and results of country specific models to identify undiagnosed individuals with Type 2 diabetes will be evaluated.
  2. In the treatment study the effects of routine care in general practice according to local and national guidelines will be compared with an intensive ADDITION protocol, including structured lifestyle education (dietary modification, increased physical activity and smoking cessation) and intensive treatment of blood glucose, blood pressure and lipids, and prophylactic aspirin with or without motivational interviewing, on mortality, macrovascular and microvascular disease. Furthermore the impact of treatment on health status, treatment satisfaction and health service costs will also be assessed.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Procedure: optimised treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3057 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The ADDITION Study. Anglo-Danish-Dutch Study of Intensive Treatment In PeOple With screeN Detected Diabetes in Primary Care
Study Start Date : January 2001
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Intervention
The 334 general practices in Denmark, United Kingdom and the Netherlands have been randomised to screening for diabetes followed by routine care (RC group) according to national guidelines, or screening followed by multifactorial treatment (IT group).
Procedure: optimised treatment

The intervention targeted individual patients and the Primary Care Team. Practitioners were trained in a target driven, intensive multifactorial approach including lifestyle advice (smoking cessation, physical activity 30 min./day and healthy diet) and pharmacological treatment with the aim of reducing the complications of diabetes as described in protocol.

The training included meetings, practice visiting, written feed back reports and reminders on controls.

Primary Outcome Measures :
  1. Cardiovascular mortality [ Time Frame: Sept 2010 ]
  2. MI (non fatal) [ Time Frame: Sept 2010 ]
  3. Stroke (non fatal) [ Time Frame: Sept 2010 ]
  4. Revascularisation (operating procedures) [ Time Frame: Sept 2010 ]
  5. Amputations, non traumatic [ Time Frame: Sept 2010 ]

Secondary Outcome Measures :
  1. All cause mortality [ Time Frame: 2010 ]
  2. Development of renal impairment [ Time Frame: 2010 ]
  3. Progression of retinopathy [ Time Frame: 2010 ]
  4. Health economy, patient and health service costs and gains [ Time Frame: 2010 ]
  5. Perceived health, SF36, AddQol [ Time Frame: 2010 ]
  6. Neuropathy, periphery and autonomy [ Time Frame: 2011 ]

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Ages Eligible for Study:   40 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Screening study: Every one aged 40-69 years (UK and DK) or 50-69 years(NL). Treatment study: All with screen detected type 2 diabetes.

Exclusion Criteria:

Participants are excluded if they already have diabetes at time of screening, are pregnant or lactating or have a severe psychotic illness, are house bound or have an illness with a likely survival of less than one year.

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): NCT00237549

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Institute of Public Health
Aarhus, Denmark, 8000
Julius Centre for health Sciences and Primary Care, University of Utrecht
Utrecht, Netherlands
United Kingdom
Department of Public Health and general Practice
Cambridge, United Kingdom, UK CB2 2SR
University Hospital and Department of Health Sciences, University of Leicster
Leicester, United Kingdom
Sponsors and Collaborators
University of Aarhus
Steno Diabetes Centre, Gentofte, Denmark
University of Cambridge
University Hospitals, Leicester
Utrecht University
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Study Chair: Torsten Lauritzen, Professor Institutute of Public Health, Dep. of General practice, Aarhus University, Denmark
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00237549    
Other Study ID Numbers: The ADDITION-study
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: December 20, 2013
Last Verified: August 2012
Keywords provided by University of Aarhus:
Type 2 diabetes
Intensive treatment
Primary care
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases