The Measurement of Insulin Resistance in Peritoneal Dialysis Patients

Study Overview
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Brief Summary
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The goal of this study is to examine the relevance of insulin resistance in peritoneal dialysis (PD) patients as well as the means to improve this metabolic derangement. We will do so through a prospective randomized study using Icodextrin as an alternate dialysate solution to routine glucose-based dialysate. We hypothesize that (1) the glucose loading associated with PD leads to impairment in insulin sensitivity, (2) the degree of insulin resistance is dependent on the basal metabolic state (fasting versus stimulated), and (3) the replacement of conventional dialysate with glucose-sparing dialysate preparations will improve insulin resistance and associated metabolic disturbances in PD patients.

Official Title
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The Measurement of Insulin Resistance in Peritoneal Dialysis Patients

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Other: Icodextrin dialysate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medically stable and receiving stable PD for ≥ 3 months; BMI ≤ 45; Most recent Kt/V ≥1.7 or Tccr ≥ 50l/week/1.73m2; On Glucose lactate-buffered PD solutions with consistent glucose exposure. Exclusion Criteria: Pregnancy or breast-feeding; Intolerance to the study protocols; Severe, unstable, active, or chronic inflammation disease (active infection, active connective tissue disorder, active cancer, HIV, liver disease); Chronic use of anti-inflammatory medication except low dose (< 10mg/d) prednisone; Severe hypokalemia (K+ level < 3.0 mEq/L); Hypercalcemia (Ca++ level > 11.0 mg/dL); Have a glycogen storage disease; Intolerant to maltose or isomaltose; Allergic to cornstarch or icodextrin; Recent abdominal surgery in the past 30 days; Chronic Obstructive Lung Disease (COPD) or Interstitial lung disease; Insulin-Dependent Diabetes Mellitus (IDDM).
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: glucose-based dialysate<br>most frequently used Standard of Care (SOC) dialysate | |
| Other: Icodextrin dialysate<br>alternate SOC dialysate | Other: Icodextrin dialysate<br>* use of alternate SOC dialysate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in glucose disposal rate |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Pearson or Spearman correlation coefficient values between insulin resistance (IR) measured by insulin clamp study and other methods (e.g., HOMA, QUICKI, OGTT) |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peritoneal Dialysis, Insulin resistance