Iqbal 2009.
| Methods | Parallel randomised controlled clinical trial | |
| Participants |
Inclusion criteria: non‐diabetic population aged 18 to 75 years with metabolic syndrome and abdominal adiposity; participants' eligibility required waist circumference ≥ 102 cm for men and ≥ 89 cm for women and at least two of the following: systolic blood pressure ≥ 130 mm Hg or diastolic blood pressure ≥ 85 mm Hg or taking ≥ 1 antihypertensive agent; fasting blood glucose ≥ 6.1 mmol/L, but < 7 mmol/L; fasting triglycerides ≥ 1.68, but ≤ 8.96 mmol/L; or HDL‐C ≤ 1 mmol/L for males and ≤ 1.29 mmol/L for females Exclusion criteria: 2‐hour plasma glucose value of ≥ 11.1 mmol/L, ASCVD, LDL‐C > 4.9 mmol/L, liver transaminases three times the upper limit of normal, renal insufficiency, fibrates or dietary supplements (excluding a multivitamin with < 100 μg chromium) Diagnostic criteria: waist circumference, BMI, according to the criteria of the National Cholesterol Education Program Adult Treatment Panel III |
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| Interventions |
Number of study centres: 1 Treatment before study: not reported Titration period: not reported |
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| Outcomes | Outcomes reported in abstract of publication: insulin sensitivity index derived from a frequently sampled intravenous glucose tolerance test. Prespecified secondary endpoints included changes in other measurements of glucose metabolism, oxidative stress, fasting serum lipids and high sensitivity C‐reactive protein | |
| Study details |
Run‐in period: 16 weeks Study terminated before regular end: no |
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| Publication details |
Language of publication: English Commercial and non‐commercial funding: this work was supported by the following grants: R21DK067241, K‐23 AT‐00058, and M01‐RR00040 (Translational Research Center [TRC]). Nutrition 21 provided active drug and placebo. Dr Boston is the principal author of the modelling software MinMod Millenium Publication status: peer review journal |
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| Stated aim for study | Quote: "To determine the effects of chromium picolinate (CrP) on glucose metabolism in patients with metabolic syndrome" | |
| Notes | Abbreviations: BMI: body mass index | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "conducted a randomised, double‐blind, placebo‐controlled study of the safety and efficacy of 16 weeks of CrPic therapy and randomised in a 1:1 double‐blind fashion to receive either CrPic or matching placebo." Comment: No other details given |
| Allocation concealment (selection bias) | Unclear risk | Comment: method of concealment is not described |
| Blinding of participants and personnel (performance bias) Objective outcomes | Unclear risk | Comment: method of blinding is not described |
| Blinding of participants and personnel (performance bias) Subjective outcomes | Low risk | Comment: no subjective outcomes |
| Blinding of outcome assessment (detection bias) Objective outcomes | Unclear risk | Comment: no details provided |
| Blinding of outcome assessment (detection bias) Subjective outcomes | Low risk | Comment: no subjective outcomes |
| Incomplete outcome data (attrition bias) Objective outcomes | Low risk | Comment: three participants withdrew for personal reasons |
| Incomplete outcome data (attrition bias) Subjective outcomes | Low risk | Comment. no subjective outcomes |
| Selective reporting (reporting bias) | Low risk | Comment: the study protocol is available and there was no selective reporting |
| Other bias | Unclear risk | Comment: the trial had a commercial source of funding possibly creating a risk of bias |