The Measurement of Insulin Resistance in Peritoneal Dialysis Patients
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Endocrine |
| Therapuetic Areas: | Endocrinology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/20/2016 |
| Start Date: | September 2010 |
| End Date: | December 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.
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.
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).
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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