DiRECT
Trial question
What is the role of primary care-led weight management in patients with T2DM?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
41.0% female
59.0% male
N = 298
298 patients (122 female, 176 male).
Inclusion criteria: patients, aged 20-65 years, diagnosed with T2DM within the past 6 years with a BMI of 27-45 kg/m², and not receiving insulin.
Key exclusion criteria: current insulin use; HbA1c ≥ 12%; weight loss ≥ 5 kg within the 6 months; severe or unstable HF; substance abuse; known cancer; MI within the previous 6 months; learning difficulties; current treatment with anti-obesity drugs.
Interventions
N=149 weight management program (withdrawal of antidiabetic and antihypertensive drugs, total diet replacement, stepped food reintroduction, and structured support for long-term weight loss maintenance).
N=149 control (best practice care by guidelines).
Primary outcome
Diabetes remission at 12 months
46%
4%
46.0 %
34.5 %
23.0 %
11.5 %
0.0 %
Weight management
program
Control
Significant
increase ▲
NNT = 2
Significant increase in diabetes remission at 12 months (46% vs. 4%; OR 19.7, 95% CI 7.8 to 49.8).
Secondary outcomes
Significant increase in the percentage of patients achieving a weight reduction of ≥ 15 kg (24% vs. 0%; AD 24%, 95% CI 12.01 to 35.99).
Significantly greater reduction in mean weight at 12 months (10 kg vs. 1 kg; AD 8.8 kg, 95% CI 7.3 to 10.3).
Significantly greater improvement in QoL, as measured by the EuroQol 5-Dimension Visual Analog Scale (7.2 points vs. -2.9 points; AD 6.4 points, 95% CI 2.5 to 10.3).
Conclusion
In patients, aged 20-65 years, diagnosed with T2DM within the past 6 years with a BMI of 27-45 kg/m², and not receiving insulin, weight management program was superior to control with respect to diabetes remission at 12 months.
Reference
Michael Ej Lean, Wilma S Leslie, Alison C Barnes et al. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet. 2018 Feb 10;391(10120):541-551.
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