Adamson AJ

Al-Mrabeh A

Barnes AC

Brosnahan N

Ford I

Hollingsworth KG

Kean S

Lean MEJ

Leslie WS

Mathers JC

McCombie L

McConnachie A

McIlvenna Y

Messow CM

Peters C

Rehackova L

Rodrigues AM

Ross HM

Sattar N

Sniehotta FF

Taylor R

Thom G

Welsh P

Zhyzhneuskaya S

Background: DiRECT reported diabetes remission at one year for 46% of participants allocated to an integrated structured weight management programme. We now assess two-year findings. Methods: DiRECT is an open-label, cluster-randomised, controlled trial in primary care practices randomised to a weight management programme (intervention) or best-practice care by guidelines (control). We recruited individuals aged 20–65 years, with &lt;6 years duration of type 2 diabetes, body-mass index 27–45 kg/m2, and not receiving insulin. The intervention comprised withdrawal of anti-diabetes and antihypertensive drugs, total diet replacement (825–853 kcal/day formula diet) for 12-20 weeks, stepped food reintroduction (2–8 weeks), and then structured support for weight loss maintenance. Co-primary outcomes, analysed hierarchically, were weight loss &gt;15 kg, and remission of diabetes, defined as HbA1c &lt;6\ub75% (&lt;48 mmol/mol) with no anti-diabetes medications. Findings: At 24 months, 53/149 (35\ub76%) of those commencing the intervention and 5/149 (3\ub74%) in the control group (adjusted odds ratio 25\ub78, 95% CI 8\ub73,80\ub78; p&lt;0\ub70001) had remission, and 11\ub74% of intervention and 2\ub70% of the control group (adjusted odds ratio 8\ub72 (2\ub72,30\ub70), p=0\ub70015) had weight loss ≥15kg. Of those maintaining ≥10kg weight loss (45/272), 64% (29/45) achieved remission, and 24.2% (36/149) of the intervention group maintained ≥10kg weight loss. Adjusted mean differences between groups were, in changes in body weight -5\ub74 kg, (-6\ub79,-4\ub70), p&lt;0\ub70001, in HbA1c -4\ub78 mmol/mol, (-8\ub73,-1\ub74), p=0\ub70063 despite &gt;50% fewer anti-diabetes agent use in intervention group, and SBP -3\ub74 mmHg, (-6\ub77,-0\ub72), p=0\ub70397. Serious adverse events were similar at 12 months, but fewer occurred in intervention than control in the second year (9 vs. 22). Quality of life improved more from baseline in the intervention than the control group, adjusted mean difference 4\ub76 (0\ub74,8\ub79, p=0\ub7032). Interpretation: This programme sustained remissions at 24 months for over a third of people with type 2 diabetes. Weight loss of ≥10 kg provides remission for two thirds. Funding: Diabetes UK. </strong

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Durability of a primary care-led weight-management intervention for remission of type 2 diabetes: 2-year results of the DiRECT open-label, cluster-randomised trial

Durability of a primary care-led weight-management intervention for remission of type 2 diabetes: 2-year results of the DiRECT open-label, cluster-randomised trial

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