Structured Weight Management Program for Diabetes REmission Clinical Trial-Australia – (DiRECT-Aus Study)

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus Type 2; Obesity; Overweight; Metabolic and Endocrine - Diabetes; Diet and Nutrition - Obesity

• Registration Number: ACTRN12620001129976
• Lead Sponsor: Diabetes NSW & ACT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-30
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

•Men and women aged 20-65 years, all ethnicities
•T2DM of duration 0-6 years
•Body mass index (BMI)>27 kg/m2

Exclusion Criteria

•Current insulin use
•HbA1c greater than 86 mmol/mol (10%) at screening
•Weight loss of greater than 5kg within the last 6 months
•Recent eGFR equals 45 ml/min/1.732
•Substance abuse
•Known cancer
•Myocardial infarction within previous 6 months
•Severe or unstable Heart Failure defined as equivalent to the New York Heart Association (NYHA):
A.Grade 3 - marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or breathlessness, and
B.Grade 4 - unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased.
•Learning difficulties
•Current treatment with anti-obesity drugs
•Diagnosed eating disorder or purging
•Pregnant/ considering pregnancy
•Patients with unstable mental illness
•People currently participating in another clinical research trial
•Allergy to Optifast or any of its ingredients

Study & Design

• Study Type: Interventional
• Study Design: Not specified