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

NCT00237549 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3057

Last updated 2013-12-20

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Steno Diabetes Centre, Gentofte, Denmark

    collaborator UNKNOWN

  • University of Cambridge

    collaborator OTHER

  • University Hospitals, Leicester

    collaborator OTHER

  • Utrecht University

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Torsten Lauritzen, Professor · Institutute of Public Health, Dep. of General practice, Aarhus University, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-01-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • Denmark
  • Netherlands
  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00237549 on ClinicalTrials.gov