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. 2017 May 10;2017(5):CD012204. doi: 10.1002/14651858.CD012204.pub2

McLaughlin 2011.

Methods Design: parallel RCT, superiority design, controlled clinical trial
Randomisation ratio: 1:1
Number of study centres: NR
Participants Inclusion criteria: aged 30‐70 years; healthy men and women, BMI 27‐37 kg/m²; FPG ≥ 100 mg/dL and ≤ 125 mg/dL or a 2‐h post OGTT ≥ 140 mg/dL or ≤ 199 mg/dL
Exclusion criteria: diabetes; active cardiac, kidney, liver, pulmonary or other major organ diseases that are cause for exclusion; other exclusionary criteria include: use of corticosteroids, diet medications or antipsychotic medications, history of eating disorder, history of bariatric surgery, active malignancy, recent weight change > 2%, inability to attend follow‐up visits, excessive alcohol use, investigator's discretion that it is not in person's best interest.
Diagnostic criteria: criteria for intermediate hyperglycaemia as defined by ADA: FPG ≥ 100 mg/dL and ≤ 125 mg/dL or a 2‐h post OGTT ≥ 140 mg/dL or ≤ 199 mg/dL
Interventions Intervention: exenatide 10 μg twice daily
Comparator: placebo
Run‐in period: none
Study drug administration free period before glucose testing during trial: NR
Extension period: none
Outcomes Composite outcome measures reported: no
Study details Trial terminated early: no
Publication details Language of publication: English
Funding: NR
Publication status: abstract
Stated aim for study Quote: "We sought to evaluate persistence of weight and metabolic benefits of exenatide in moderately‐obese prediabetics one year after discontinuing the drug."
Notes Contacted investigator Dr Tracey, but the trial is not yet published as an article
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "In a double blinded, randomized controlled design ..."
Comment: method of random sequence generation not adequately described
Allocation concealment (selection bias) Unclear risk Quote: "In a double blinded, randomized controlled design ..."
Comment: method of allocation concealment not adequately described
Selective reporting (reporting bias) High risk Comment: stated in abstract that fasting blood glucose and 2‐h blood glucose were measured, but data not reported in a way that they could be included in review. Useable data might be available in updates
Other bias Unclear risk Comment: funding source NR