Table 3.
Diet | Conclusion statement | No. of participants (no. of studies) | Certainty in the evidencea | Comments |
---|---|---|---|---|
TDR | TDR leads to a large increase in T2D remission by a median of 54% from baseline (range 46–61%), when compared with standard care (4–12%). | 445 (2 RCTs) |
⊕⊕⊕⊕ HIGH |
Low-risk-of-bias RCTs, pre-specified outcomes with power calculation |
Meal replacement | Meal replacement likely leads to T2D remission by 11% from baseline, when compared with standard care plus diabetes education (2%). | 4503 (1 RCT) |
⊕⊕◯ MODERATE Due to possible publication bias |
Ancillary observational analysis of RCT |
Mediterranean diet | Mediterranean diet may lead to T2D remission by 15% from baseline, when compared with LFD (4%). | 215 (1 RCT) |
⊕⊕◯◯ LOW Due to imprecisionb and possible publication bias |
Small sample size, and ancillary observational analysis of RCT |
Very low carbohydrate ketogenic diet | The evidence is very uncertain about the effect of ketogenic diet on T2D remission due to serious risk of bias of the study methods and imprecision, although one non-RCT reported a remission rate of 20%, compared with no remission in usual care with diabetes education. | 349 (1 non-RCT) |
⊕◯◯◯ VERY LOW Due to serious risk of bias (rated down 2 levels) and imprecisionb |
Lack of randomisation, uncontrolled confounding, selection bias, incomplete outcome data, possible selective reporting, imprecision and imbalance between groups |
VLED (food based) | The evidence is very uncertain about the effect of food-based VLED on T2D remission, although one small uncontrolled intervention study reported a remission rate of 22%. | 9 (1 single group uncontrolled intervention) |
⊕◯◯◯ VERY LOW Due to critical risk of bias (rated down 3 levels), imprecision and potential publication bias |
Lack of randomisation, uncontrolled confounding, selection bias and selective reporting of result. Only one positive, small study |
Remission is defined as either HbA1c < 48 mmol/mol (<6.5%) or fasting plasma glucose <7 mmol/l and no glucose-lowering medication
aGRADE level for certainty of evidence: ‘high’ indicates that we are very confident that the true effect lies close to that of the estimate of the effect; ‘moderate’ indicates that we are moderately confident in the effect estimate (the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different); ‘low’ indicates that our confidence in the effect estimate is limited (the true effect may be substantially different from the estimate of the effect); and ‘very low’ indicates that we have very little confidence in the effect estimate (the true effect is likely to be substantially different from the estimate of effect)
bRated down one level due to imprecision, as the sample size is less than an optimal information size of 400
T2D, type 2 diabetes; TDR, total diet replacement