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. 2016 Nov 29;2016(11):CD012436. doi: 10.1002/14651858.CD012436

Prado 2012.

Methods Parallel randomised controlled trial, randomisation ratio 1:1, superiority design
Participants Inclusion criteria:
  • obese adolescents (BMI > 95th percentile for age and sex)

  • postmenarchal

  • aged 13 to 19 years

  • ≥ 1 risk factor for type 2 diabetes


Exclusion criteria:
  • diagnosis of diabetes mellitus type 1 or 2

  • kidney diseases

  • liver or respiratory alcoholism

  • eating disorders

  • other psychiatric disorders that could diminish adherence to treatment

  • hypersensitivity to metformin

  • pharmacological treatments by metabolic or nutritional impact during the last 3 months

  • pregnancy


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
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
Outcomes Outcomes reported in abstract of publication: weight, BMI, metabolic risk profile
Study details Run‐in period: no
Trial terminated early: no
Publication details Language of publication: Spanish
Noncommercial funding
Publication status: peer‐reviewed journal
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