Prado 2012.
Methods | Parallel randomised controlled trial, randomisation ratio 1:1, superiority design | |
Participants |
Inclusion criteria:
Exclusion criteria:
Diagnostic criteria: obesity defined as BMI > 95th percentile for age and sex. Risk factors for type 2 diabetes include first‐ or second‐degree relative with a history of type 2 diabetes, or alteration in the results of the following examinations within the past 6 months: glycaemia fasting ≥ 100 mg/dL, postload glucose ≥ 140 mg/dL or HOMA > 3.0 |
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Interventions |
Intervention: metformin + nutritional guide + exercise programme Comparator: placebo + nutritional guide + exercise programme Number of trial centres: 1 Treatment before trial: none Titration period: no |
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Outcomes | Outcomes reported in abstract of publication: weight, BMI, metabolic risk profile | |
Study details |
Run‐in period: no Trial terminated early: no |
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Publication details |
Language of publication: Spanish Noncommercial funding Publication status: peer‐reviewed journal |
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Stated aim for study | Quote from publication: "To analyze the anthropometric and metabolic impact of metformin in obese adolescents at risk for type 2 diabetes" | |
Notes | ‐ | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk |
Quote: "Recruited adolescents were randomly assigned into two groups (A and B) through a sequence computational randomization" Comment: an appropriate randomisation method was used |
Allocation concealment (selection bias) | Low risk |
Quote: "An external laboratory was in charge of packing and labelling bottles, keeping content knowledge in confidence until the study ended" Comment: there was allocation concealment |
Blinding of participants and personnel (performance bias) Objective outcomes | Low risk | Comment: author confirmed participants and trial personnel were blinded |
Blinding of participants and personnel (performance bias) Subjective outcomes | Low risk | Comment: author confirmed participants and trial personnel were blinded |
Blinding of outcome assessment (detection bias) Objective outcomes | Unclear risk | Comment: unclear if outcome assessment was blinded and if this would have results in detection bias for the objective outcomes |
Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | Comment: unclear if outcome assessment was blinded and if this would have results in detection bias for the subjective outcomes |
Incomplete outcome data (attrition bias) Objective outcomes | High risk | Comment: there was no imputation method to replace missing data and dropout rates were fairly high |
Incomplete outcome data (attrition bias) Subjective outcomes | High risk | Comment: there was no imputation method to replace missing data and dropout rates were fairly high |
Selective reporting (reporting bias) | Unclear risk | Comment: do not give follow‐up data for some outcomes such as blood pressure |
Other bias | Unclear risk | Comment: unable to make an assessment on other bias due to lack of information |