Trial of lifestyle intervention by group care in the management of type 2 diabetes (ROMEO Trial)

Completed

• Conditions: Type 2 diabetes; Nutritional, Metabolic, Endocrine; Non-insulin-dependent diabetes mellitus

• Registration Number: ISRCTN19509463
• Lead Sponsor: niversity of Turin (Italy)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-10
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 532

Inclusion Criteria

1. Outpatients with non insulin-treated type 2 diabetes millitus (T2DM) of at least 1 year known duration
2. Both males and females, aged <80
3. Normally followed in a diabetes centre

Exclusion Criteria

1. New diagnosis of diabetes
2. Age <40 or >80
3. Insulin treatment
4. Established psychiatric problems
5. Presence of terminal illness

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Clinical outcomes<br>1.1.Glycated haemoglobin, measured every 3 months for 4 years<br>1.2. Low-density lipoprotein (LDL) cholesterol, assessed yearly for 4 years<br>1.3. Systolic and diastolic blood pressure, measured every 3 months for 4 years<br>2. Cognitive and psychological outcomes<br>2.1. Quality of life, assessed yearly for 4 years<br>2.2. Knowledge of diabetes, assessed every 2 years for 4 years<br>2.3. Health behaviours, assessed yearly for 4 years

Secondary Outcome Measures

Name	Time	Method
1. Cardiovascular events, followed up for 4 years<br>2. Cost-effectiveness analysis at 4 years