| Methods |
Trial Design: RCT
Randomisation procedure: not stated, randomly assigned crossover design
Allocation concealment: not reported
Blinding: not reported
Intention to treat analysis: no |
| Participants |
Country: Australia
Setting: community
Number: 28 (7 dropouts), 21 analysed
Age: 57.4 ± 2.9 years
Sex: 14 males, 7 females
Body mass: 87 ± 3 kg
Inclusion criteria: NIDDM but no history of renal disease, retinopathy or vascular problems
Other characteristics: 16 subjects treated with oral hypoglycaemic agents (sulphonylureas and metformin) and 5 by diet alone. Drug dosage was not altered during study. |
| Interventions |
Trial intervention: low‐GI diet (GI=63 GI units using glucose =100)
comparison intervention: high‐GI diet (GI=43 GI units)
Duration of each intervention: 4 weeks with no washout period between interventions |
| Outcomes |
Main outcome measures: fructosamine, glycated plasma protein (%)
Other outcomes: plasma insulin, urinary glucose, urinary C‐peptide, plasma lipids, plasma glucose, body weight |
| Notes |
Source of funding: CSIRO Human Nutrition
Drop‐outs: 7 (due to work commitments and illness unrelated to diabetes) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
