The Measurement of Insulin Resistance in Peritoneal Dialysis Patients

Not Applicable

Completed

• Conditions: End Stage Renal Disease
• Interventions: Other: Icodextrin dialysate

• Registration Number: NCT01119196
• Lead Sponsor: Vanderbilt University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-05
• Study First Submitted QC: 2010-05-05
• Study First Posted: 2010-05-07
• Study Start: 2010-09
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-22
• Last Update Posted: 2016-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Icodextrin dialysate	Icodextrin dialysate	alternate SOC dialysate

Primary Outcome Measures

Name	Time	Method
improvement in glucose disposal rate	12 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States