Lu 2010.
| Methods | Parallel randomised controlled trial, randomisation ratio 1:1 | |
| Participants |
Inclusion criteria: (1) participants with pre‐diabetes; (2) 25 to 80 years old; (3) twice increased fasting blood glucose (fasting blood glucose 5.6 mmol/L to 6.9 mmol/L); (4) postprandial blood glucose was increased (OGTT 2‐hour blood glucose 7.8 mmol/L to 11.1 mmol/L). Exclusion criteria: (1) participants with cardiovascular diseases, hepatitis, kidney diseases and other basic diseases that may increase the risk of intervention; (2) participants who may affect the process of the experiment: inability to follow up, refusal of random grouping, pregnancy and lactation, etc., (3) participants were taking drugs that could interfere with the test results, such as diuretics, beta‐blockers 13 and glucocorticoids. Diagnostic criteria: ADA 2009 (fasting blood glucose 5.6 mmol/L to 6.9 mmol/L or 2‐hour blood glucose 7.8 mmol/L to 11.1 mmol/L). |
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| 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 |
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| Outcomes | Composite outcome measures reported: none | |
| Study details |
Trial identifier: unregistered Trial terminated early (for benefit/because of adverse events): no |
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| Publication details |
Language of publication: Chinese Funding: not reported Publication status: peer‐reviewed journal, full article |
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| Stated aim of study | Quote from publication: "This study is a clinical demonstration study on lifestyle adjustment and metformin intervention, two commonly used measures to prevent or delay diabetes. Through the comparison and analysis of the blood glucose index changes after the implementation, the compliance of the two kinds of intervention measures, weight changes, the incidence of adverse events and other indicators, the efficacy and safety were reasonably evaluated, and the most reasonable, effective and practical measures for preventing or delaying diabetes were finally determined." | |
| 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: "A total of 100 patients in the lifestyle intervention group completed the study, 17 patients withdrew from the study (2 patients went abroad, 15 patients for personal reasons), and the baseline characteristics of those who did not complete the study were the same as those who completed the study. 111 patients (6 without follow‐up) entered the primary and secondary endpoint analysis. In the metformin group, 21 patients withdrew from the study (6 with gastrointestinal reactions, lO with personal reasons, 5 with other reasons), and 115 patients entered the primary and secondary endpoint analysis (2 without follow‐up)."; "last observation carried forward (LOCF) was used"; "Since our study included observational studies of compliance, our analysis showed that the LOCF did not affect the interpretation of the results of this study." Comment: reported, acceptable reason, and appropriate imputation of data (reported and reasons explained) |
| Incomplete outcome data (attrition bias) measures of blood glucose control | Low risk |
Quote from publication: "A total of 100 patients in the lifestyle intervention group completed the study, 17 patients withdrew from the study (2 patients went abroad, 15 patients for personal reasons), and the baseline characteristics of those who did not complete the study were the same as those who completed the study. 111 patients (6 without follow‐up) entered the primary and secondary endpoint analysis. In the metformin group, 21 patients withdrew from the study (6 with gastrointestinal reactions, lO with personal reasons, 5 with other reasons), and 115 patients entered the primary and secondary endpoint analysis (2 without follow‐up)."; "last observation carried forward (LOCF) was used"; "Since our study included observational studies of compliance, our analysis showed that the LOCF did not affect the interpretation of the results of this study." Comment: reported, acceptable reason, and appropriate imputation of data (reported and reasons explained) |
| Selective reporting (reporting bias) | Unclear risk | Comment: protocol unavailable |
| Other bias | Unclear risk | Comment: unknown funding source |