Methods | RCT | |
Participants | People with well controlled type I diabetes mellitus (Canada) CVD risk: moderate Intervention reduced fat: 18 randomised, 15 analysed Intervention modified fat: 17 randomised, 15 analysed Mean years in trial: reduced fat 0.46, modified fat 0.47 % male: reduced fat unclear, modified fat unclear Age, years: 37.9 (8.1 SD) (not specified by study arm) |
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Interventions | Reduced fat vs Modified fat diet Reduced fat aims: total fat 27-30%E, SFA ≤10%E, MUFA 10%, CHO 54-57% Modified fat aims: total fat 37-40%E, SFA ≤10%E, MUFA 20%E, CHO 43-46%E Reduced fat methods: after initial dietary advice monitored weekly by phone by a dietitian (24 hour food recall). Glycaemia, insulin doses, CHO at meals, hypoglycaemic attacks all self-monitored daily and reported weekly Modified fat methods: after initial dietary advice monitored weekly by phone by a dietitian (24 hour food recall). Glycaemia, insulin doses, CHO at meals, hypoglycaemic attacks all self-monitored daily and reported weekly Total fat intake (at 6 months): not stated Saturated fat intake (at 6 months): not stated Style: diet advice Setting: community |
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Outcomes | Stated trial outcomes: Triglycerides and other CVD risk factors Data available on total mortality? yes (no events) Cardiovascular mortality? yes (no events) Events available for combined cardiovascular events: none Secondary outcomes: cancer deaths (no events) and cancer diagnoses (no events) Tertiary outcomes: weight; BMI; total, LDL and HDL cholesterol; TGs; systolic and diastolic blood pressure |
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Notes | ||
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “randomly assigned” |
Allocation concealment (selection bias) | Unclear risk | No details provided |
Blinding (performance bias and detection bias) All outcomes |
High risk | No details provided, but participants had to make decisions about what they ate |
Incomplete outcome data (attrition bias) All outcomes |
High risk | Data reported for those who completed |
Selective reporting (reporting bias) | Unclear risk | Unclear |
Other bias | Low risk | |
Free of systematic difference in care? | Low risk | Similar intervention in both groups |
Free of dietary differences other than fat? | Low risk | Focus on fat and CHO intake |