Jin 2009.
| Methods | Parallel randomised controlled trial, randomisation ratio 1:1:1 | |
| Participants |
Inclusion criteria: IFG Exclusion criteria: severe cardiovascular and cerebrovascular diseases and obvious abnormal liver and kidney functions Diagnostic criteria: IFG diagnosed from WHO 1999 criteria (FPG between 6.1 mmol/L to 6.9 mmol /L, 2‐hour postprandial blood glucose (2hPG) < 7.8 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 outcomes measures reported: none | |
| Study details | Trial terminated early (for benefit/because of adverse events): no | |
| Publication details |
Language of publication: Chinese Funding: non‐commercial (government funding) Publication status: peer‐reviewed, full‐article |
|
| Stated aim of study | Quote from publication: "To observe the changes of islet cell function and insulin resistance (IR) in patients with impaired fasting glucose after different methods of intervention, and to explore the pathogenesis and intervention pathway of IFG." | |
| 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 |
Quote from publication: "During the treatment, 1 patient in the rosiglitazone group had facial edema and 2 patients in the rosiglitazone group had intolerance of both lower limbs and withdrew from the study. Three patients in the metformin group were withdrawn from the study due to severe gastrointestinal reactions. No significant adverse reactions or hypoglycemia were observed in other patients." Comment: PP analysis was used (reported and reasons explained) |
| Incomplete outcome data (attrition bias) measures of blood glucose control | High risk |
Quote from publication: "During the treatment, 1 patient in the rosiglitazone group had facial edema and 2 patients in the rosiglitazone group had intolerance of both lower limbs and withdrew from the study. Three patients in the metformin group were withdrawn from the study due to severe gastrointestinal reactions. No significant adverse reactions or hypoglycemia were observed in other patients." Comment: PP analysis was used (reported and reasons explained) |
| Selective reporting (reporting bias) | Unclear risk | Comment: protocol unavailable |
| Other bias | Low risk | Comment: no other risk of bias identified |