Effect of Rosiglitazone on Vascular Function in Patients with Advanced Chronic Kidney Disease

Completed

• Conditions: Advanced Chronic kidney disease; Vascular function; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12605000690651
• Lead Sponsor: Raine Medical Research foundation (pending)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Post-ischaemic flow-mediated dilatation of the brachial artery.[After 8 weeks of treatment];2. Systemic arterial compliance (a measure of arterial elasticity)[After 8 weeks of treatment];3. Augmentation Index (a measure of arterial stiffness)[After 8 weeks of treatment]

Secondary Outcome Measures

Name	Time	Method
1. Pulse wave velocity and pulse wave velocity index[After 8 weeks of treatment];2. Insulin sensitivity as measured by a euglycaemic clamp and the HOMA score[After 8 weeks of treatment];3. Cholesterol, triglycerides, LDL-cholesterol, HDL-cholesterol, apolipoprotein B, and AI concentration[After 8 weeks of treatment];4. Markers of inflammation (CRP, IL-6) and thrombosis (fibrinogen, plasminogen activator inhibitor - PAI-1).[After 8 weeks of treatment];5. 24-hour ambulatory blood pressure[After 8 weeks of treatment]