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

This study has been completed.
Sponsor:
Collaborators:
Steno Diabetes Centre, Gentofte, Denmark
University of Cambridge
University Hospitals, Leicester
Utrecht University
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00237549
First received: October 10, 2005
Last updated: December 19, 2013
Last verified: August 2012
  Purpose

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 Intervention
Type 2 Diabetes
Procedure: optimised treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Cardiovascular mortality [ Time Frame: Sept 2010 ] [ Designated as safety issue: No ]
  • MI (non fatal) [ Time Frame: Sept 2010 ] [ Designated as safety issue: No ]
  • Stroke (non fatal) [ Time Frame: Sept 2010 ] [ Designated as safety issue: No ]
  • Revascularisation (operating procedures) [ Time Frame: Sept 2010 ] [ Designated as safety issue: No ]
  • Amputations, non traumatic [ Time Frame: Sept 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All cause mortality [ Time Frame: 2010 ] [ Designated as safety issue: No ]
  • Development of renal impairment [ Time Frame: 2010 ] [ Designated as safety issue: No ]
  • Progression of retinopathy [ Time Frame: 2010 ] [ Designated as safety issue: No ]
  • Health economy, patient and health service costs and gains [ Time Frame: 2010 ] [ Designated as safety issue: No ]
  • Perceived health, SF36, AddQol [ Time Frame: 2010 ] [ Designated as safety issue: No ]
  • Neuropathy, periphery and autonomy [ Time Frame: 2011 ] [ Designated as safety issue: No ]

Enrollment: 3057
Study Start Date: January 2001
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  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: NCT00237549

Locations
Denmark
Institute of Public Health
Aarhus, Denmark, 8000
Netherlands
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
Investigators
Study Chair: Torsten Lauritzen, Professor Institutute of Public Health, Dep. of General practice, Aarhus University, Denmark
  More Information

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

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00237549     History of Changes
Other Study ID Numbers: The ADDITION-study
Study First Received: October 10, 2005
Last Updated: December 19, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Type 2 diabetes
Screening
Intensive treatment
Polypharmacy
Primary care

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 28, 2014