ifestyle Intervention for early diabetes: A randomised controlled trial

Not Applicable

• Conditions: Type 2 Diabetes; Cardiovascular disease risk; health service utilisation; Psychological distress; Metabolic and Endocrine - Diabetes; Cardiovascular - Other cardiovascular diseases; Public Health - Health service research

• Registration Number: ACTRN12611000295943
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Aged 18 years or more
With newly identified (within 24 months at the time of intervention) T2DM
Able to attend a 1-week residential program in and 4 X 3 hour booster sessions held over the subsequent 14 week period.
Willing to undertake significant lifestyle change

Exclusion Criteria

Patients who are unable to provide informed consent
Patients who are unable to communicate adequately in English
Patients who are cognitively impaired or in an altered conscious state
Patients that are receiving palliative care
Patients who have commenced sulfonylreas as an adjunct to metformin to treat their diabetes

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
For all patients the primary outcome will be glycaemic control operationalised as HbA1c level.[Baseline (study entry) and 12 months post-intervention];The percentage of patients achieving normal glycaemic control as assessed using fasting BSL (using WHO definition) and HbA1c (defined as a haemoglobin A1c <8%).[Baseline (study entry) and 12 months post-intervention]