McLaughlin 2011.
Methods |
Design: parallel RCT, superiority design, controlled clinical trial Randomisation ratio: 1:1 Number of study centres: NR |
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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 |
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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 |
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Outcomes | Composite outcome measures reported: no | |
Study details | Trial terminated early: no | |
Publication details |
Language of publication: English Funding: NR Publication status: abstract |
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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 |