Atabek 2008.
Methods | Parallel randomised controlled trial, randomisation ratio 3:1 (intervention:control), superiority design | |
Participants |
Inclusion criteria:
Exclusion criteria:
Diagnostic criteria: see above |
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Interventions |
Intervention: metformin + diet and physical activity advice Comparator: placebo + diet and physical activity advice Number of trial centres: 1 Treatment before trial: none Titration period: no |
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Outcomes | Outcomes reported in abstract of publication: BMI, fasting insulin, 120‐min insulin levels, FGIR, HOMA‐IR, QUICKI | |
Study details |
Run‐in period: no Trial terminated early: no |
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Publication details |
Language of publication: English Funding: no information given Publication status: peer‐reviewed journal |
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Stated aim for study | Quote from publication: "To determine whether metformin treatment for 6 months is effective in reducing body weight and hyperinsulinaemia and also ameliorating insulin sensitivity indices in obese adolescents with hyperinsulinaemia" | |
Notes | ‐ | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: no description of randomisation process |
Allocation concealment (selection bias) | Unclear risk | Comment: no description of how allocation was concealed |
Blinding of participants and personnel (performance bias) Objective outcomes | Unclear risk |
Quote: "a 6 month, randomized, double‐blind placebo‐controlled, parallel‐group, prospective clinical trial" Comment: unsure who was blinded |
Blinding of participants and personnel (performance bias) Subjective outcomes | Unclear risk |
Quote: "a 6 month, randomized, double‐blind placebo‐controlled, parallel‐group, prospective clinical trial" Comment: unsure who was blinded |
Blinding of outcome assessment (detection bias) Objective outcomes | Unclear risk |
Quote: "a 6 month, randomized, double‐blind placebo‐controlled, parallel‐group, prospective clinical trial." Comment: unsure who was blinded |
Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk |
Quote: "a 6 month, randomized, double‐blind placebo‐controlled, parallel‐group, prospective clinical trial" Comment: unsure who was blinded |
Incomplete outcome data (attrition bias) Objective outcomes | Unclear risk | Comment: the trial did not report the number of dropouts, or clarify there were no dropouts |
Incomplete outcome data (attrition bias) Subjective outcomes | Unclear risk | Comment: the trial did not report the number of dropouts, or clarify there were no dropouts |
Selective reporting (reporting bias) | High risk |
Quote: "A detailed questionnaire on food consumption was completed at the beginning and at the end of the trial medication period" Comment: no results shown for food consumption data. Also, very unclear on the number lost to follow‐up and what type of analyses were conducted |
Other bias | High risk | Comment: there was uncertainty to whether this was a randomised controlled trial or a matched controlled trial. Concern arose over a lack of description about randomisation, blinding and allocation. No rationale for the size of intervention group and no calculation of power. They also do not declare who funded the trial |