Methods |
Trial Design: RCT
Randomisation procedure: random number tables
Allocation concealment: not reported
Blinding of outcome assessors: not reported
Intention to treat analysis: no |
Participants |
Country: UK
Setting: Community
Number: 60
Age: intervention group 54 ± 2 years; comparison group 56 ± 3 years
Sex: low‐GI diet group 16 males, 9 females, control group 20 males, 6 females
Inclusion criteria: newly diagnosed type 2 diabetes
Exclusion criteria: pregnant or lactating women, subjects aged more than 70 years, patients with other endocrine or lipid disorders, had received dietary advice previously, requiring oral hypoglycaemic or insulin therapy, patients where language barrier made instruction difficult
Other characteristics: BMI: low‐GI group 30.1± 0.0 kg/m2, control group 29.1 ± 1.3 kg/m2 |
Interventions |
Trial intervention: 12 weeks low glycaemic index diet GI= 77 ± 1
comparison intervention: 12 weeks standard dietary advice GI= 82 ± 1
Duration: 12 weeks |
Outcomes |
Main outcome measure: fructosamine
Other outcomes: fasting blood glucose, cholesterol, triglycerides, body weight |
Notes |
Source of funding: British Diabetic Association
Drop‐outs: 9, as they failed to complete the study as they did not attend the final appointment (5 in intervention group, 4 in comparison group) |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
Unclear risk |
B ‐ Unclear |