The Measurement of Insulin Resistance in Peritoneal Dialysis Patients

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Alp Ikizler, Vanderbilt University Identifier:
First received: May 5, 2010
Last updated: January 18, 2016
Last verified: January 2016
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.

Condition Intervention
End Stage Renal Disease
Other: Icodextrin dialysate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Measurement of Insulin Resistance in Peritoneal Dialysis Patients

Resource links provided by NLM:

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • improvement in glucose disposal rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the Pearson or Spearman correlation coefficient values between IR measured by insulin clamp study and other methods (e.g., HOMA, QUICKI, OGTT) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: September 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: glucose-based dialysate
most frequently used SOC dialysate
Icodextrin dialysate
alternate SOC dialysate
Other: Icodextrin dialysate
use of alternate SOC dialysate


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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).
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Please refer to this study by its identifier: NCT01119196

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Principal Investigator: Alp Ikizler, MD Vanderbilt University
  More Information

Responsible Party: Alp Ikizler, Professor, Vanderbilt University Identifier: NCT01119196     History of Changes
Other Study ID Numbers: 100177 
Study First Received: May 5, 2010
Last Updated: January 18, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Peritoneal Dialysis
Insulin resistance

Additional relevant MeSH terms:
Insulin Resistance
Kidney Failure, Chronic
Glucose Metabolism Disorders
Kidney Diseases
Metabolic Diseases
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases
Dialysis Solutions
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses processed this record on May 04, 2016