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| autoid | 25 |
| crg_id | CRG090500014 |
| titleoftrial | The Effect of Rosiglitazone on Vascular Function in Patients with Advanced Chronic Kidney Disease |
| acronymnoftrial | |
| website | http:// |
| identificationno | |
| leadprefix | Dr |
| leadsurname | Chan |
| leadgivennames | Doris |
| leadposition | Research Fellow |
| leaddepartment | Nephrology |
| leadorganisation | Royal Perth Hospital |
| leadaddress | Wellington Street Campus, Wellington Street, Perth, Western Australia 6000 |
| leademail | doris.chan@health.wa.gov.au |
| leadphone | +61 8 9224 2244 |
| leadfax | +61 8 9224 2160 |
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| funding | ngo |
| otherfunding | |
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| ethicsapproval | |
| studytype | randomised |
| studytype_other | |
| groupassignment | parallel |
| blinding_patients | yes |
| blinding_investigators | yes |
| blinding_outcomes | yes |
| blinding_analysts | no |
| proposedstart | 01/02/2006 |
| actualstart | |
| proposedcompletiondate | |
| actualcompletiondate | |
| multi_center_study | no |
| numberofcentres | |
| multi_national_study | |
| countrycentres | Australia |
| researchquestion | People with chronic kidney disease have a markedly increased risk of heart disease, which could in part be due to reduced sensitivity to insulin (a know predictor of heart disease) that develops with the onset of kidney failure. Abnormal blood vessel function is an early indicator of heart disease and can be measured using simple non-invasive methods. Improving insulin sensitivity with thiazolidinedione medication such as rosiglitazone also improves blood pressure, inflammation and blood fats. These changes may collectively improve blood vessel function and lower risk for heart disease. The effect of rosiglitazone on blood vessel function has not been studied in people with kidney failure. This study examines the effect of rosiglitazone compared with placebo on blood vessel function in people with moderate to severe kidney failure. |
| study_status_recruitment | not_yet_recruiting |
| study_status_recruitment_follow | |
| healthcarecondition | Chronic renal failure |
| intervention1 | Rosiglitazone |
| intervention2 | |
| intervention3 | |
| intervention4 | |
| participants_gender | both |
| participants_other | adults |
| age | 18 - 75 years |
| totalrecruitment | 70 |
| inclusion | All patients on haemodialysis or peritoneal dialysis for Chronic kidney disease, Patients should be stable on dialysis for at least 6 months with adequate indices of dialysis (Fractional Reduction of Urea, FRU > 0.67 or Kt/V > 0.3); All patients with moderate-to-severe stages 3-5 chronic kidney disease (GFR < 60ml/min); Age range 18 – 75 years, male and female. Patients will be selected for having the Metabolic Syndrome as defined by the WHO criteria [31] based on our previous data showing that these patients had markedly impaired vascular function: 1. Insulin resistance identified by 1 of the following: Type 2 diabetes, impaired fasting glucose > 6.1 mmol/L, impaired glucose tolerance or increased fasting insulin > 75th percentile for the population (8 mU/L). PLUS ANY 2 OF THE FOLLOWING: 1. Antihypertensive medication and/or systolic blood pressure >= 140mmHg or diastolic blood pressure >= 90 mmHg. 2. Plasma triglycerides > 1.7 mmol/L 3. HDL-cholesterol < 0.9 mmol/L in men and < 1.0 mmol/L in women 4. Body mass index > 30 kg/m2 and/or waist:hip ratio > 0.9 in men and 0.85 in women 5. Urinary albumin excretion rate <= 20 microg/min |
| exclusion | Type 1 diabetes mellitus; Nephrotic-range proteinuria; Liver enzymes > 2 times upper limit of normal; Alcohol consumption > 3 standard drinks/day; Immunosuppressive therapy for renal transplantation; Cardiovascular event or unstable cardiovascular disease in preceding 6 months; Symptomatic or NYHA heart failure stage III or IV; Hb < 110g/L; Significant psychiatric disorder; Active infection or inflammation. |
| primaryoutcomes | 1. Post-ischaemic flow-mediated dilatation of the brachial artery. 2. Systemic arterial compliance (a measure of arterial elasticity) 3. Augmentation Index (a measure of arterial stiffness) |
| secondaryoutcomes | 1. Pulse wave velocity and pulse wave velocity index 2. Insulin sensitivity as measured by a euglycaemic clamp and the HOMA score 3. Cholesterol, triglycerides, LDL-cholesterol, HDL-cholesterol, apolipoprotein B, and AI concentration 4. Markers of inflammation (CRP, IL-6) and thrombosis (fibrinogen, plasminogen activator inhibitor - PAI-1). 5. 24-hour ambulatory blood pressure |
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