For adults aged 18–45 with obesity and early-onset type 2 diabetes, an intensive diet-and-exercise programme produced remission in 54% of participants after 24 weeks, compared with 4% receiving usual care.
Researchers randomly assigned 96 participants between September 24, 2021, and June 6, 2025, with 50 allocated to the intensive intervention and 46 to standard care. The trial was conducted at three research centres in England and Canada affiliated with the University of Leicester UK, McGill University Montreal, and the University of Alberta Edmonton.
Remission required an HbA1c level below 6.5%, equivalent to 48 mmol/mol, with no glucose-lowering medication for at least 12 weeks.
By the end of the programme, 27 of the 50 participants on the diet and exercise plan met that threshold, against 2 of 46 in standard care. After statistical adjustment, those in the intensive programme were 21 times more likely to achieve remission.
For the first 12 weeks, participants followed a diet of 800 to 900 calories a day, made up of 30% protein, 50% carbohydrate and 20% fat. They attended supervised aerobic and resistance training twice a week and completed one exercise session independently each week.
All meals were replaced with specially formulated nutritional products during the first two weeks, using Optifast in the UK and ProtiDiet in Canada.
The restricted diet brought early side effects. Participants reported constipation, headaches, dizziness and fatigue, though the symptoms resolved over time. At least one adverse event was recorded in 43 of the 50 intervention participants, compared with 6 of the 46 receiving standard care. No severe adverse events were reported.
From weeks 13–24, participants moved to a diet intended to maintain their weight loss and continued to exercise independently.
Among 47 intervention participants with available weight data, average weight fell from 100.7 kg to 92.3 kg, a reduction of 8.4 kg over 24 weeks. The 43 control participants with available data lost 1.2 kg on average, from 103.2 kg to 102.0 kg.
After adjustment, the intervention group lost an average of 7.5 kg more than the control group, including an additional 6.6 kg of fat loss.
Final assessments were completed by 86 of those enrolled, or 90%. The findings were published in The Lancet Regional Health Americas.
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