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. Author manuscript; available in PMC: 2014 Sep 15.
Published in final edited form as: Cochrane Database Syst Rev. 2011 Jul 6;(7):CD002137. doi: 10.1002/14651858.CD002137.pub2
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
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
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)
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