Ji 2011.
| Methods | Parallel randomised controlled trial, randomisation ratio 1:1:1 | |
| Participants |
Inclusion criteria: no history of diabetes or autoimmune disease, and no acute or chronic infection within 2 weeks before enrolment, IFG and/or IGT. Exclusion criteria: not reported Diagnostic criteria: WHO 1999 (IGT (2hPG between 7.8 mmol/L and 11.0 mmol/L); or IFG (FPG between 6.1 mmoL/L and 6.9 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: no | |
| Publication details |
Language of publication: Chinese Funding: non‐commercial funding (governmental funding) Publication status: peer‐reviewed journal, full‐article |
|
| Stated aim of study | Quote from publication: "To observe the changes of serum, hs‐crp and insulin sensitivity index before and after metformin treatment or intensive lifestyle intervention in patients with prediabetes." | |
| 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 | Low risk |
Quote from publication: "No patients were discontinued due to adverse drug reactions." Comment: reported (no missing data) |
| Incomplete outcome data (attrition bias) measures of blood glucose control | Low risk |
Quote from publication: "No patients were discontinued due to adverse drug reactions." Comment: reported (no missing data) |
| Selective reporting (reporting bias) | High risk | Comment: protocol unavailable. Adverse events not reported. Likely to have been assessed and evaluated during the study |
| Other bias | Low risk | Comment: no other risk of bias identified |