Li 2009.
| Methods | Parallel randomised controlled trial, randomisation ratio 1:1 | |
| Participants |
Inclusion criteria: obesity (BMI of 25 kg/m2 or more) and impaired regulation of glucose Exclusion criteria: not reported Diagnostic criteria: WHO 1999 (FPG between 6.1 mmol/L to 6.9 mmol/L, 2‐hour glucose (2hPG) between 7.8 mmol/Lto 11.0 mmol/L) |
|
| Interventions |
Number of study centres: 1 Run‐in period: not reported Administration‐free period before testing during trial: not specified if any study drug was taken on the testing day at the end of intervention Extension period: none |
|
| Outcomes | Composite outcome measures reported: none | |
| Study details | Trial terminated early (for benefit/because of adverse events): no | |
| Publication details |
Language of publication: Chinese Funding: not reported Publication status: peer‐reviewed journal, full article |
|
| Stated aim of study | Quote from publication: "In this study, metformin was used to treat obese people with impaired regulation of mixed sugars, so as to explore the methods of diabetes intervention." | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Quote from publication: "randomised" Comment: insufficient information about the sequence generation process |
| Allocation concealment (selection bias) | Unclear risk | Comment: no description of allocation concealment |
| Blinding of participants and personnel (performance bias) incidence of T2DM | Low risk | Comment: no blinding reported, however, laboratory indexes are unlikely to be influenced by lack of blinding (investigator‐assessed outcome measurement) |
| Blinding of participants and personnel (performance bias) measures of blood glucose control | Low risk | Comment: no blinding reported, however, laboratory indexes are unlikely to be influenced by lack of blinding (investigator‐assessed outcome measurement) |
| Blinding of outcome assessment (detection bias) incidence of T2DM | Low risk | Comment: no blinding reported, however, laboratory indexes are unlikely to be influenced by lack of blinding (investigator‐assessed outcome measurement) |
| Blinding of outcome assessment (detection bias) measures of blood glucose control | Low risk | Comment: no blinding reported, however, laboratory indexes are unlikely to be influenced by lack of blinding (investigator‐assessed outcome measurement) |
| Incomplete outcome data (attrition bias) incidence of T2DM | High risk | Comment: a total of 7 participants (3:4) lost to follow‐up, no explanation provided, PP analysis was used (only reported) |
| Incomplete outcome data (attrition bias) measures of blood glucose control | Low risk | Comment: a total of 7 participants (3:4) lost to follow‐up, no explanation provided, ITT analysis was used (only reported) |
| Selective reporting (reporting bias) | Unclear risk | Comment: protocol unavailable |
| Other bias | Unclear risk | Comment: unknown funding source |