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Completed

NCT Number: NCT01119196

The Measurement of Insulin Resistance in Peritoneal Dialysis Patients

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.

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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Icodextrin dialysate

Other

use of alternate SOC dialysate

Primary outcomes

  1. improvement in glucose disposal rate

    Time frame: 12 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
May 7, 2010
Registry last updated
Sep 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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