None listed
Conditions
Interventions
Randomised, double blind, placebo-controlled, parallel-group study of rosiglitazone 4mg/day vs placebo for 8 weeks
Sponsors
Raine Medical Research foundation (pending)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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); 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/L3. HDL-cholesterol < 0.9 mmol/L in men and < 1.0 mmol/L in women4. Body mass index > 30 kg/m2 and/or waist:hip ratio > 0.9 in men and 0.85 in women5. Urinary albumin excretion rate >= 20 microg/min.
Exclusion criteria
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.
Outcome results
None listed