Methods |
Trial Design: RCT
Randomisation procedure: not reported, randomly allocated crossover design
Allocation concealment: not reported
Blinding of outcome assessors: not reported
Intention to treat analysis: no |
Participants |
Country: Mexico
Setting: community
Number: 36 (14 completed study)
Age: 53 ± 9 years
Sex: of 14 who completed study 6 male, 8 female
Inclusion criteria: type 2 diabetes with BMI >25 kg/m2
Other characteristics: mean diabetes duration 8 ± 7 years, BMI 30 ± 6 kg/m2, mean fasting glucose 9.5 mmol/L, mean A1c 8.4% |
Interventions |
Trial intervention: low glycaemic index diet
comparison intervention:
high glycaemic index diet
Duration: crossover design 2 x 6 week periods with 6 week washout period in between |
Outcomes |
Main outcome measures: % glycated haemoglobin, weight, fasting serum glucose, BMI, body mass, serum lipids |
Notes |
Source of funding: Omnilife‐Conacyt
Drop‐outs: accounted for, 4 dropped out during the low‐GI diet, 8 during the high‐GI diet and 10 did not complete records |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
Unclear risk |
B ‐ Unclear |