| Methods |
Trial Design: RCT
Randomisation procedure: randomly assigned crossover design
Allocation concealment: not reported
Blinding of
outcome assessors: Not reported
Intention to treat analysis: Yes |
| Participants |
Country: Australia
Setting: Community
Number: 16 in crossover design
Age: 62 ± 9 yr
Sex: 6 female, 10 male
Inclusion criteria: well‐controlled NIDDM (defined by the National Diabetes Data Group), no history of ketosis or brittle diabetes, insidious onset of diabetes with minimal symptoms
Other characteristics: mean duration of diabetes 5 yr (range 1‐22 yr), body mass 75.9 ± 14.1 kg. Body Mass Index 25 ± 5 kg/m2. All subjects in good healthy except for diabetes. Ten participants on sulfonylureas plus diet therapy, and six on diet therapy alone. Medication was not altered during study. |
| Interventions |
Trial intervention: low glycaemic index diet
comparison intervention: high glycaemic index diet
Duration: 12 weeks |
| Outcomes |
Main outcome measures: %HbA1c, weight, fasting plasma glucose, urinary glucose, plama cholesterol, plasma triglycerides, low‐ and high‐ density lipoprotein cholesterol |
| Notes |
Source of funding: Sydney University Nutrition Research Foundation, CSL‐Novo Pty Ltd, Apex‐Australian Diabetes Foundation
Drop‐outs: no |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
