The Measurement of Insulin Resistance in Peritoneal Dialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01119196
Recruitment Status : Completed
First Posted : May 7, 2010
Last Update Posted : September 26, 2016
Information provided by (Responsible Party):
Alp Ikizler, 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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Other: Icodextrin dialysate Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Measurement of Insulin Resistance in Peritoneal Dialysis Patients
Study Start Date : September 2010
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: glucose-based dialysate
most frequently used Standard of Care (SOC) dialysate
Icodextrin dialysate
alternate SOC dialysate
Other: Icodextrin dialysate
use of alternate SOC dialysate

Primary Outcome Measures :
  1. improvement in glucose disposal rate [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. the Pearson or Spearman correlation coefficient values between insulin resistance (IR) measured by insulin clamp study and other methods (e.g., HOMA, QUICKI, OGTT) [ Time Frame: 12 weeks ]

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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 Medical Center

Responsible Party: Alp Ikizler, Professor, Vanderbilt University Identifier: NCT01119196     History of Changes
Other Study ID Numbers: 100177
First Posted: May 7, 2010    Key Record Dates
Last Update Posted: September 26, 2016
Last Verified: September 2016

Keywords provided by Alp Ikizler, Vanderbilt University:
Peritoneal Dialysis
Insulin resistance

Additional relevant MeSH terms:
Insulin Resistance
Kidney Failure, Chronic
Glucose Metabolism Disorders
Metabolic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Dialysis Solutions
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmaceutical Solutions