The Measurement of Insulin Resistance in Peritoneal Dialysis Patients

Vanderbilt University

Status

Completed

Conditions

End Stage Renal Disease

Treatments

Other: Icodextrin dialysate

Study type

Interventional

Funder types

Other

Identifiers

NCT01119196

100177

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Volunteers

No Healthy Volunteers

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).