| Methods |
Trial Design: RCT
Randomisation procedure: not stated, randomly allocated crossover design
Allocation concealment: not reported
Blinding: not reported
Intention to treat analysis: yes |
| Participants |
Country: France
Setting: community
Number: 12
Age: 54 ± 2 years
Sex: 12 males
Body mass: 93 ± 3 kg,
Inclusion criteria: type 2 diabetes Other characteristics: BMI 31 ± 1 kg/m2, fasting glycaemia 8.7 ± 0.7 mmol/L, 11 men on antidiabetic agents and 1 on dietary regime alone.
Exclusion criteria: abnormal renal, hepatic and thyroid functions |
| Interventions |
Trial intervention: low‐GI diet
comparison intervention: high‐GI diet (GI= GI units)
Duration of each intervention: 4 weeks with 4 week washout period between interventions |
| Outcomes |
Main outcome measures: % glycated haemoglobin
Other outcomes: plasma glucose, plasma insulin, plasma lipids, body weight |
| Notes |
Source of funding: INSERM
Drop‐outs: no |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
