Ludvik 2002.
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: no information Treatment before study: diabetic diet Titration period: nil Experimental intervention groups:
Participants in each group received 4 tablets 3 times daily after meals for a period of 6 weeks. A total of 2 g and 4 g/day were ingested by participants in each group, respectively Control intervention: Placebo tablets. No information on the contents of these tablets All patients 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 Seondary outcome(s): (as stated in the publication) change in plasma insulin level, serum cholesterol and weight Additional outcome(s): incidence of adverse events |
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Study details |
Run‐in period: no information Was s tudy terminated early (for benefit/because of adverse events): no |
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Publication details |
Language of publication: English Commercial funding: grant from manufacturer Publication status: peer review journal |
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Stated aim of study | Quote from publication: "To assess the effect of caiapo on glucose metabolism, its tolerability and mode of action in male Caucasian type 2 diabetic patients". | |
Notes | Letter to editor. Pilot study | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote from publication: "randomised to receive placebo or 2 (low dose) or 4 g (high dose) caiapo" Comment: there was no description of generation of the random sequence; furthermore, reports of 2 other trials by the same principal investigators that used a similar intervention also provided no information about sequence generation |
Allocation concealment (selection bias) | Unclear risk | Comment: there was no information provided about the method 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 concerning blinding |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: fasting blood glucose was specifically accessed at each visit for each participant |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: all participants completed the study, no treatment withdrawals or major adverse events reported |
Selective reporting (reporting bias) | Low risk | Comment: primary outcomes were stated |
Other bias | Unclear risk | Comment: there was no information about the sample size calculation or exclusion criteria; there was also insufficient information to assess other important risks of bias |