Comparison of Oxidative Stress and Insulin Resistance Before and After Using Physioneal in Peritoneal Dialysis Patients
Condition: Kidney Failure,Chronic
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Insulin Resistance
Study type: Interventional

Summary: 
      Patients affected by end-stage renal disease (ESRD) are subjected to enhanced oxidative
      stress, as a result of reduced anti-oxidant systems and increased pro-oxidant activity.
      Besides, insulin resistance is also very common in ESRD patients. Both enhanced oxidative
      stress and insulin resistance increase the risk of atherosclerosis and cardiovascular
      mortality, and intention to reduce oxidative stress and insulin resistance is important in
      ESRD patients who suffer from high cardiovascular risk.

      The high concentration of glucose and glucose degradation products (GDP), high lactate, and
      low pH in conventional peritoneal dialysis (PD) solutions are known as bioincompatible
      factors, which are believed to increase oxidative stress in PD patients. Physioneal®, a more
      biocompatible dialysis solution with neutral pH, physiologic bicarbonate concentration and
      low GDP level, has been applied in Europe for several years. Previous studies of Physioneal®
      have revealed advantages of improved infusion pain, more efficient acid-base control,
      increased ultrafiltration, and reduced peritonitis duration. However, its effects on
      oxidative stress and insulin resistance in peritoneal dialysis patients are not reported yet.
      The comparison of oxidative stress and insulin resistance before and after using Physioneal®
      may help to elucidate the possibly beneficial effects on uremic patients, which frequently
      suffer from increased oxidative stress and insulin resistance.

      Thirty continuous ambulatory peritoneal dialysis (CAPD) patients will be selected in this
      study, and receive conventional solution (Dianeal® PD-2 or PD-4) for a baseline period of 3
      months. Then Physioneal® will be used for 3 months. Clinical conditions, biochemical and
      hematological parameters, oxidative markers in blood and effluent, and insulin resistance
      will be measured at baseline, before and after Physioneal®, and some markers will be measured
      1 month after discontinuing Physioneal® and changing back to conventional solution. The
      medication used in each patient will be recorded, and the dialysis prescription will be
      adjusted by a nephrologist according to clinical data. The data collected before and after
      Physioneal® will be analyzed by paired-t test.
    

Detailed description: 
      Patients affected by end-stage renal disease (ESRD) are subjected to enhanced oxidative
      stress, as a result of reduced anti-oxidant systems and increased pro-oxidant activity.
      Enhanced oxidative stress in uremic patients increases the risk of atherosclerosis and
      cardiovascular mortality. Furthermore, bioincompatibility of dialysis therapy further
      increases oxidative stress. High concentration of glucose, high lactate, low pH, and/or high
      concentration of glucose degradation products (GDP) are known as bioincompatible factors and
      believed to increase oxidative stress in peritoneal dialysis patients. A more biocompatible
      dialysis solution, i.e., neutral pH, containing physiologic concentration of bicarbonate and
      low concentration of GDP has been developed. There is a growing body of in vitro studies
      showing this neutral bicarbonate containing dialysis solution more biocompatible compared to
      conventional solutions. However, its effects on oxidative stress in peritoneal dialysis
      patients are not reported yet. On the other hand, insulin resistance is associated with
      cardiovascular disease, and it is very common in uremic patients. Some animal studies
      suggested that reduced oxidative stress enhanced insulin sensitivity, and the effects of
      reduced oxidative stress in human have not been extensively investigated. Previous studies of
      Physioneal®, a kind of more biocompatible dialysis solution which contains bicarbonate, have
      revealed advantages of improved infusion pain, more efficient acid-base control, increased
      ultrafiltration, and reduced peritonitis duration. The comparison of oxidative stress and
      insulin resistance before and after using Physioneal®, may help to elucidate the possibly
      beneficial effects on uremic patients, which frequently suffer from increased oxidative
      stress and insulin resistance.
    

Intervention name(s): Physioneal
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Physioneal; Peritoneal dialysis; Oxidative stress; insulin resistance