Ludvik 2008.
| Methods | Parallel RCT Randomisation ratio: 1:1 Superiority design |
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| Participants |
Inclusion criteria: clinically stable T2DM on diet only Exclusion criteria: no information Diagnostic criteria: authors' criteria |
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| Interventions |
Number of study centres: multiple centres (no information on exact number) Treatment before study: no hypoglycaemic drugs 4 weeks prior to baseline visit Titration period: nil Intervention group: 4 g of Caiopo (Ipomoea batatas) once daily Control intervention: Placebo tablets; no information provided about the content of these tablets All participants were on diet regimen during the study |
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| Outcomes |
Outcomes reported in abstract of publication: Primary outcome(s): (as stated in the publication) change in fasting blood glucose and 2‐hour postprandial blood glucose; change in HbA1c Seondary outcome(s): (as stated in the publication) change in cholesterol and triglyceride levels Additional outcome(s): incidence of adverse events |
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| Study details |
Run‐in period: medications that affect blood glucose levels such as corticosteroids, high‐dose diuretics or beta‐blockers were stopped during the 2 weeks prior to screening and for the duration of the study; screening for participants took place 1 month prior to start of study; hypoglycaemic drugs were withdrawn 4 weeks before the start of the study Was s tudy terminated early (for benefit/because of adverse events): no |
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| Publication details |
Language of publication: English Commercial other funding: grant from manufacturer Non‐commercial funding: nil Publication status: peer review journal |
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| Stated aim of study | Quote from publication: "To further evaluate the mode of action of Caiapo on insulin sensitivity over an extended period of time as well as the effects on fibrinogen and other markers of low‐grade inflammation". | |
| Notes | Original research journal article | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote from publication: "randomised" Comment: there was no information provided about the process used to generate the random sequence |
| Allocation concealment (selection bias) | Unclear risk | Comment: there was no information provided about the adequacy of allocation concealment |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote from publication: "double‐blind" Comment: there was no other information available about blinding |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: the primary and secondary outcomes were measured objectively |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Quote from publication: "27/88 patients dropped out (due to pregnancy (1) and non‐compliance to follow‐up visits)" Comment: there was no information about the number of participants who dropped out of the intervention and the control groups |
| Selective reporting (reporting bias) | Low risk | Comment: important primary and secondary outcomes were adequately reported |
| Other bias | Low risk | Comment: none detected |
RCT: randomised controlled trial; T2DM: type 2 diabetes mellitus