Brasnyó 2011.
Methods | Study design: parallel randomised controlled clinical trial | |
Participants |
Inclusion criteria
Exclusion criteria
Diagnostic criteria: quote from publication: "A total of nineteen Caucasian male patients previously diagnosed with type 2 diabetes (according to the WHO diagnostic guidelines) were included in the study" Setting: outpatients Age group: adults Gender distribution: males Country where study was performed: Hungary |
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Interventions |
Intervention(s): trans‐resveratrol Comparator(s): placebo Duration of intervention: 4 weeks Duration of follow‐up: 4 weeks Run‐in period: 4 weeks Number of study centres: 1 Extension period: none |
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Outcomes | Reported outcome(s) in full text of publication: insulin resistance/sensitivity, creatinine normalised ortho‐tyrosine level in urine samples (as a measure of oxidative stress), incretin levels, and phosphorylated protein kinase B (pAkt):protein kinase B (Akt) ratio in platelets | |
Study details |
Trial identifier: none Study terminated early: no |
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Publication details |
Language of publication: English Funding: "The present study received no specific grant from any funding agency in the public, commercial or not‐for‐profit sectors" Publication status: peer‐reviewed journal |
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Stated aim for study | Quote from publication: "To determine whether the polyphenol resveratrol improves insulin sensitivity in type 2 diabetic patients and to gain some insight into the mechanism of its action" | |
Notes | "Resveratrol of herbal origin (with > 98% t‐resveratrol content) and the placebo (both in gelatin capsules) were obtained from Argina Nutraceuticals (previously Admarc Nutraceuticals, Fót,
Hungary) and dosed 5 mg/capsule. The identical placebo capsules contained only the carrier microcrystalline cellulose" "The general examination was followed by a 4‐week washout period before the trial began (during which all lipid‐lowering medication was ceased)" |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote from publication: "They underwent a blinded randomisation into two groups: ten patients to receive oral resveratrol twice daily (in gelatin capsules containing 5 mg resveratrol) and nine patients to placebo" |
Allocation concealment (selection bias) | Unclear risk | Comment: not reported |
Blinding of participants and personnel (performance bias) adverse events | Low risk |
Quote from publication: "nineteen patients enrolled in the 4‐week long double‐blind study were randomly assigned into two groups" "The identical placebo capsules contained only the carrier microcrystalline cellulose" |
Blinding of participants and personnel (performance bias) all‐cause mortality | Low risk |
Quote from publication: "nineteen patients enrolled in the 4‐week long double‐blind study were randomly assigned into two groups" "The identical placebo capsules contained only the carrier microcrystalline cellulose" |
Blinding of participants and personnel (performance bias) insulin sensitivity | Low risk |
Quote from publication: "nineteen patients enrolled in the 4‐week long double‐blind study were randomly assigned into two groups" "The identical placebo capsules contained only the carrier microcrystalline cellulose" |
Blinding of outcome assessment (detection bias) adverse events | Unclear risk | Comment: not reported |
Blinding of outcome assessment (detection bias) all‐cause mortality | Low risk | Comment: not reported; outcome measure unlikely influenced by potential lack of blinding |
Blinding of outcome assessment (detection bias) insulin sensitivity | Low risk | Comment: not reported; outcome measure unlikely influenced by potential lack of blinding |
Incomplete outcome data (attrition bias) adverse events | Low risk | Comment: no missing data |
Incomplete outcome data (attrition bias) all‐cause mortality | Low risk | Comment: no missing data |
Incomplete outcome data (attrition bias) insulin sensitivity | Low risk | Comment: no missing data |
Selective reporting (reporting bias) | Unclear risk | Comment: protocol not available |
Other bias | Low risk | Comment: none detected |