Diabetologia · 2026
Time-restricted eating versus dietetic guidance on glycaemic outcomes in adults at risk of type 2 diabetes: a non-inferiority randomised clinical trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеEquivalence TrialНазвание и аннотация: Перевод пока не подготовлен
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Parr Evelyn B, Charrouf Rasha, Hutchison Amy T, Flint Steve A, Teong Xiao Tong, Vincent Andrew D, Bravo-Garcia Ana Paula, Siviour Zoe, Wittert Gary A, Brennan Leah, Devlin Brooke L, Hawley John A, Heilbronn Leonie K
Аннотация
AIMS/HYPOTHESIS: Time-restricted eating (TRE) consolidates daily energy intake to a consistent 6-10 h window. The aim was to assess whether TRE is non-inferior to individualised dietetic guidance (IDG) in changing HbA1c at 4 months in adults at risk of type 2 diabetes.
METHODS: In a two-arm, parallel-group, multi-centre randomised, non-inferiority clinical trial at two Australian clinical research institutes, adults at risk of type 2 diabetes (i.e. with overweight or obesity and a score of ≥15 on the Australian type 2 diabetes risk assessment tool) were recruited. Participants were randomly assigned using an electronic system (1:1) to TRE (9 h, self-selected eating window, last eating occasion by 19:00 hours) or IDG. Staff conducting assessments and analyses were blinded to allocation; participants and dietitians were unblinded. Both groups received five personalised telehealth consultations between 0 and 3 months (3 h total), specific to their allocated group. The primary outcome was the between-group difference for change in HbA1c at 4 months assessed via covariate linear regression using multiple imputation with a non-inferiority margin set at 1.1 mmol/mol (0.10%). Secondary outcomes were change in HbA1c at 12 months and changes in fasting glucose, insulin, HOMA-IR and nocturnal glucose AUC. Exploratory outcomes included changes in cardiometabolic outcomes and body mass and composition. Adverse events were tracked for 12 months.
RESULTS: One hundred and twenty four participants were randomised to TRE and 123 to IDG (mean ± SD HbA1c: 40 ± 3 mmol/mol [5.8 ± 0.3%]). At 4 months, TRE was non-inferior but not superior to IDG for HbA1c (mean [95% CI]: -0.22 [-0.72, 0.30] mmol/mol; -0.02 [-0.07, 0.03]%; p=0.40). At 12 months, the upper bound of the difference between groups was larger than the non-inferiority margin (0.10%) meaning that non-inferiority could no longer be concluded (mean [95% CI]: 0.47 [-0.19, 1.23] mmol/mol; 0.05 [-0.02, 0.11]%; p=0.14). However, the absolute changes in HbA1c were small and not clinically meaningful in either group at either time point. Adverse events were minor and not different between interventions.
CONCLUSIONS/INTERPRETATION: TRE may offer a pragmatic and practical short-term alternative when access to dietetic support is limited, or if the approach is preferred by an individual.
TRIAL REGISTRATION: ClinicalTrials.gov; NCT04762251 FUNDING: This research was funded by the Australian Government Medical Research Future Fund (MRFF 1200555).
METHODS: In a two-arm, parallel-group, multi-centre randomised, non-inferiority clinical trial at two Australian clinical research institutes, adults at risk of type 2 diabetes (i.e. with overweight or obesity and a score of ≥15 on the Australian type 2 diabetes risk assessment tool) were recruited. Participants were randomly assigned using an electronic system (1:1) to TRE (9 h, self-selected eating window, last eating occasion by 19:00 hours) or IDG. Staff conducting assessments and analyses were blinded to allocation; participants and dietitians were unblinded. Both groups received five personalised telehealth consultations between 0 and 3 months (3 h total), specific to their allocated group. The primary outcome was the between-group difference for change in HbA1c at 4 months assessed via covariate linear regression using multiple imputation with a non-inferiority margin set at 1.1 mmol/mol (0.10%). Secondary outcomes were change in HbA1c at 12 months and changes in fasting glucose, insulin, HOMA-IR and nocturnal glucose AUC. Exploratory outcomes included changes in cardiometabolic outcomes and body mass and composition. Adverse events were tracked for 12 months.
RESULTS: One hundred and twenty four participants were randomised to TRE and 123 to IDG (mean ± SD HbA1c: 40 ± 3 mmol/mol [5.8 ± 0.3%]). At 4 months, TRE was non-inferior but not superior to IDG for HbA1c (mean [95% CI]: -0.22 [-0.72, 0.30] mmol/mol; -0.02 [-0.07, 0.03]%; p=0.40). At 12 months, the upper bound of the difference between groups was larger than the non-inferiority margin (0.10%) meaning that non-inferiority could no longer be concluded (mean [95% CI]: 0.47 [-0.19, 1.23] mmol/mol; 0.05 [-0.02, 0.11]%; p=0.14). However, the absolute changes in HbA1c were small and not clinically meaningful in either group at either time point. Adverse events were minor and not different between interventions.
CONCLUSIONS/INTERPRETATION: TRE may offer a pragmatic and practical short-term alternative when access to dietetic support is limited, or if the approach is preferred by an individual.
TRIAL REGISTRATION: ClinicalTrials.gov; NCT04762251 FUNDING: This research was funded by the Australian Government Medical Research Future Fund (MRFF 1200555).