Methods | RCT | |
Participants | Adults with newly diagnosed diabetes (The Netherlands) CVD risk: moderate Control: 51 randomised, unclear how many analysed (all analysed re deaths) Intervention: 51 randomised, unclear how many analysed (all re deaths) Mean years in trial: unclear (max duration 6 years) % male: 56% overall Age: mean unclear Baseline total fat intake: int cont Baseline saturated fat intake: int cont |
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Interventions | Modified fat vs usual diet Control aims: SFA 35%E, CHO 50%E, protein 15%E Intervention aims: total fat 40%E, 1/3 linoleic acid, CHO 45%E, protein 15%E Control methods: unclear, surveyed by dietitian Intervention methods: unclear, surveyed by dietitian Total fat intake: mod fat unclear, cont unclear Saturated fat intake: mod fat unclear, cont unclear Style: diet advice? Setting: community |
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Outcomes | Stated trial outcomes: progression of diabetic retinopathy Data available on total mortality? no Cardiovascular mortality? no Events available for combined cardiovascular events: total MI and angina Secondary outcomes: none Tertiary outcomes: total cholesterol, TGs (data read off graph) |
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Notes | ||
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants matched in pairs then randomised |
Allocation concealment (selection bias) | Unclear risk | Randomisation method not clearly described |
Blinding (performance bias and detection bias) All outcomes |
High risk | Neither participants nor physicians appear blinded |
Incomplete outcome data (attrition bias) All outcomes |
Unclear risk | Unclear, deaths, cancer and CV events are drop-outs, trialists asked for data - unclear if any data missing |
Selective reporting (reporting bias) | Low risk | Not relevant for primary and secondary outcomes as all trialists asked for data |
Other bias | Low risk | |
Free of systematic difference in care? | Unclear risk | Level and type of intervention unclear. See Control and Intervention Methods in Interventions section of the Table of Characteristics of Included Studies |
Free of dietary differences other than fat? | Low risk | State that fibre and dietary cholesterol were similar in control and intervention. See Control and Intervention Aims in Interventions section of the Table of Characteristics of Included Studies |