The Measurement of Insulin Resistance in Peritoneal Dialysis Patients
Completed · Not applicable
Conditions studied: End Stage Renal Disease
In brief
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.
Key facts
- Study ID
- NCT01119196
- Run by
- Vanderbilt University
- People needed
- 10
- Starts
- 2010-09-01
- Expected to finish
- 2015-01-01
- Last updated by the study team
- 2016-09-26
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.