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The Measurement of Insulin Resistance in Peritoneal Dialysis Patients

This study is currently recruiting participants.
Verified January 2013 by Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
Alp Ikizler, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01119196
First received: May 5, 2010
Last updated: January 21, 2013
Last verified: January 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

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 2014
Estimated Primary Completion Date: December 2014 (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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01119196

Contacts
Contact: Cindy Booker, LPN 615-343-5828 cindy.a.booker@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Cindy Booker, LPN     615-322-4698     cindy.a.booker@vanderbilt.edu    
Principal Investigator: Alp Ikizler, MD            
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Alp Ikizler, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: Alp Ikizler, Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01119196     History of Changes
Other Study ID Numbers: 100177
Study First Received: May 5, 2010
Last Updated: January 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Peritoneal Dialysis
Insulin resistance

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

ClinicalTrials.gov processed this record on May 23, 2013