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

Atabek 2008.

Methods Parallel randomised controlled trial, randomisation ratio 3:1 (intervention:control), superiority design
Participants Inclusion criteria:
  • BMI ≥ 95th percentile for age and sex based on the standards of the CDC


Exclusion criteria:
  • children were excluded if they had prior major illness, including type 1 or type 2 diabetes mellitus

  • took medications or had a condition known to influence body composition, insulin action, or insulin secretion

  • none of the participants had a history of diabetes mellitus


Diagnostic criteria: see above
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
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
Publication details Language of publication: English
Funding: no information given
Publication status: peer‐reviewed journal
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